NOVEMBER
2001
WEEK ENDING NOVEMBER 3
PRODUCT AND CODE: Aspirin tablets
(uncoated), 325 mg., bottles of 100, 200, 250, 500, and 1,000 count
Aspirin
tablets (coated), 325 mg., bottles of 100, 200, 250, 300, 500, and 1,000 count,
and bulk drums of 50,000
Both
types of tablets, coated and uncoated were produced under York's label and
numerous private labels as follows:
Uncoated:
1.
York Aspirin, 100-ct., 200-ct., 500-ct. and 1,000-ct., responsible firm: York
Pharmaceuticals, Inc., Kansas City, KS
2.
York Aspirin Russian label, 100-ct., responsible firm: York Pharmaceuticals,
Inc., Kansas City, KS, or York Pharmaceutical Co., Brookfield, MO
3.
Health Care Aspirin, 100-ct. and 200-ct., responsible firm: Great Lakes Sales,
Wyoming, MI
4.
Homebest Aspirin, 100-ct. and 250-ct., responsible firm: Glendale Foods, Inc.,
Hazelwood, MO
5.
DG Aspirin (Dollar General on case label only), 200-ct. and 500-ct.,
responsible firm: Dolgencorp, Inc., Scottsville, KY
6.
Aspirin, 1,000-ct. (Vitatrade on case label only), responsible firm: Catholic
Medical Mission Board, New York, NY
7.
HyTop Aspirin, 100-ct. and 250-ct., responsible firm: Federated Group,
Arlington Heights, IL
8. Parade Aspirin, 250-ct. and 500-ct.,
responsible firm: Federated Group, Arlington Heights, IL
Coated:
1.
York Aspirin Analgesic Lite-Coat, 100-ct. and 200-ct., responsible firm: York
Pharmaceuticals, Inc., Kansas City, KS
2.
Parade Micro Coated Aspirin, 100-ct., 250-ct. and 500-ct., responsible firm:
Federated Group, Arlington Heights, IL
3.
HyTop Coated Aspirin, 100-ct. and 250-ct., responsible firm Federated Group,
Arlington Heights, IL
4.
Smart Choice Lite-Coat Aspirin, 100-ct., responsible firm: National
Distribution Network, Merrick, NY
5.
Our Family Coated Aspirin, 100-ct., 300-ct., and 500-ct., responsible firm:
Nash Finch Company, Minneapolis, MN
6.
Welby Lightly Coated Aspirin, 200-ct., responsible firm: Aldi, Inc., Batavia,
IL
7.
DeMoulas Market Basket Aspirin Film Coated, 100-ct. and 500-ct., responsible
firm: Demoulas & Market Basket Stores, Tewksbury, MA
8.
Southern Home Aspirin Coated Regular Strength, 100-ct. and 300-ct., responsible
firm: Southern Home, Birmingham, AL
9.
Quality Choice Micro Thin Coating Aspirin, 100-ct., responsible firm: Quality
Choice, Novi, MI
10.
Snyder Micro Coated Aspirin, 100-ct., 300-ct., 500-ct., and 1,000-ct.,
responsible firm: Snyder's Drug Stores, Inc., Minnetonka, MN
11.
Navarro Lite Coat Aspirin, 100-ct., 250-ct. and 500-ct., responsible firm:
Navarro Discount Pharmacies, Inc., Miami, FL
12.
Conney Aspirin USP Lightly Coated, 100-ct. and 1,000-ct., responsible firm:
Conney Safety Products Co., Inc., Madison, WI
13.
Discount Drug Mart Food Fair Film Coated Aspirin, 200-ct., responsible firm:
Drug Mart-Food Fair, Medina, OH
14.
Medic Drug Coated Aspirin, 100-ct. and 250-ct., responsible firm: Medic Drug
Co., Inc., Cleveland, OH
15.
Vi-Jon Coated Aspirin, 100 ct., responsible firm: The ViJon Co., St. Louis, MO
16. Bulk aspirin 325 mg. tablets coated,
50,000-ct.
Codes:
Lot
# Exp. Date Description
9909018 Sep 01 Conney 1,000 ct. Coated
9910089 Sep 01 HyTop 250 ct.
9911001 Sep 01 Dollar General 200 ct.
9910042 Sep 01 Parade 100 ct. Coated
0002036 Sep 01 Navarro 250 ct. Coated
9910033 Oct 01 Parade 100 ct. Coated
9910045 Oct 01 Smart Choice 100 ct. Coated
9910057 Oct 01 HyTop 100 ct.
9910073 Oct 01 HyTop 100 ct.
9910087 Oct 01 Russian 100 ct.
9910095 Oct 01 Russian 100 ct.
9910096 Oct 01 Russian 100 ct.
9910105 Oct 01 Russian 100 ct.
9910115 Oct 01 York 200 ct.
9910120 Oct 01 Dollar General 200 ct.
9911005 Oct 01 Dollar General 200 ct.
9911023 Oct 01 Homebest 250 ct.
9911035 Oct 01 Parade 250 ct.
9911048 Oct 01 Dollar General 500 ct.
9911061 Oct 01 Snyder 500 ct. Coated
9911067 Oct 01 Parade 100 ct. Coated
9911098 Oct 01 Health Care 100 ct.
9911161 Oct 01 York 100
ct.
9911174 Oct 01 York 100 ct. Coated
9912095 Oct 01 Dollar General 200 ct.
9912120 Oct 01 Dollar General 200 ct.
0002032 Oct 01 Parade 250 ct. Coated
0002131 Oct 01 Vitatrade 1,000 ct.
9911052 Nov 01 Dollar General 500 ct.
9911055 Nov 01 York 500 ct.
9911080 Nov 01 Homebest 100 ct.
9911081 Nov 01 Health Care 100 ct.
9911101 Nov 01 Health Care 200 ct.
9911116 Nov 01 Welby 200 ct. Coated
9911129 Nov 01 Welby 200 ct. Coated
9911140 Nov 01 Homebest 100 ct.
9911146 Nov 01 Our Family 500 ct. Coated
9911160 Nov 01 Parade 500 ct. Coated
9911180 Nov 01 Homebest 100ct.
9912003 Nov 01 Our Family 300 ct. Coated
9912004 Nov 01 Our Family 300 ct.
9912005 Nov 01 Snyder 300 ct. Coated
9912025 Nov 01 Southern Home 300 ct. Coated
9912030 Nov 01 Our Family 100 ct. Coated
9912031 Nov 01 Navarro 100 ct. Coated
9912040 Nov 01 Smart Choice 100 ct. Coated
9912054 Nov 01 Southern Home 100 ct. Coated
9912055 Nov 01 HyTop 100 ct. Coated
9912086 Nov 01 York 100 ct. Coated
9912126 Nov 01 Vitatrade 1,000 ct.
0001102 Nov 01 Southern Home 100 ct. Coated
0001109 Nov 01 York 100 ct. Coated
0002045 Nov 01 York 200 ct. Coated
9912044 Dec 01 Vitatrade 1,000 ct.
9912096 Dec 01 Welby 200 ct. Coated
9912130 Dec 01 Parade 250 ct.
9912141 Dec 01 Vitatrade 1,000 ct.
9912148 Dec 01 Welby 200 ct. Coated
9912150 Dec 01 Vitatrade 1,000 ct.
9912151 Dec 01 Vitatrade 1,000 ct.
9912158 Dec 01 Vitatrade 1,000 ct.
0001011 Dec 01 Dollar General 200 ct.
0001021 Dec 01 Dollar General 200 ct.
0001023 Dec 01 Dollar General 200 ct.
0001085 Dec 01 York 100 ct. Coated
0001105 Dec 01 Dollar
General 500 ct.
9912063 Jan 02 Navarro 250 ct.
0001026 Jan 02 HyTop 250 ct.
0001027 Jan 02 York 200 ct.
0001056 Jan 02 HyTop 100 ct.
0001059 Jan 02 Health Care 100 ct.
0001103 Jan 02 York 100 ct.
Coated
0001106 Jan 02 Dollar General 500 ct.
0001114 Jan 02 Parade 500 ct.
0001117 Jan 02 Parade 500 ct. Coated
0001118 Jan 02 Navarro 500 ct. Coated
0001126 Jan 02 Southern Home 100 ct. Coated
0001128 Jan 02 Snyder 500 ct. Coated
0001129 Jan 02 Dollar General 200 ct.
0002011 Jan 02 Dollar General 200 ct.
0002013 Jan 02 Our Family 500 ct. Coated
0002014 Jan 02 Our Family 500 ct. Coated
0002016 Jan 02 York 500 ct.
0002018 Jan 02 York 100 ct.
0002019 Jan 02 Drug Mart 200 ct. Coated
0002050 Jan 02 York 200 ct. Coated
0002053 Jan 02 Our Family 100 ct. Coated
0002058 Jan 02 York 200 ct. Coated
0002061 Jan 02 BULK COATED
0002122 Jan 02 Vitatrade 1,000 ct.
0002123 Jan 02 Vitatrade 1,000 ct.
0002124 Jan 02 Vitatrade 1,000 ct.
0002039 Feb 02 Our Family 300 ct.
0002060 Feb 02 Dollar General 200 Ct.
0002093 Feb 02 Southern Home 300 ct. Coated
0002096 Feb 02 Conney 100 ct. Coated
0002097 Feb 02 Snyder 100 ct. Coated
0002112 Feb 02 Vitatrade 1,000 ct.
0002115 Feb 02 Our Family
500 ct. Coated
0002136 Feb 02 Vitatrade 1,000 ct.
0002137 Feb 02 Snyder 300 ct. Coated
0002140 Feb 02 Vitatrade 1,000 ct.
0002141 Feb 02 Snyder 300 ct. Coated
0002148 Feb 02 Vitatrade 1,000 ct.
0002149 Feb 02 York 100 ct.
0002150 Feb 02 York 100 ct.
0002153 Feb 02 Vitatrade 1,000 ct.
0002158 Feb 02 Our Family 300 ct. Coated
0002161 Feb 02 Navarro 100 ct. Coated
0002163 Feb 02 Our Family 300 ct.
0003002 Feb 02 Homebest 250 ct.
0003007 Feb 02 HyTop 250 ct. Coated
0003030 Feb 02 Vitatrade 1,000 ct.
0003034 Feb 02 Medic 250 ct. Coated
0003040 Feb 02 Medic 250 ct. Coated
0003031 Mar 02 Dollar General 200 ct.
0003038 Mar 02 York 100 ct.
0003042 Mar 02 Vitatrade 1,000 ct.
0003050 Mar 02 Dollar General 200 ct.
0003054 Mar 02 Dollar General 200 ct.
0003063 Mar 02 Health Care 200 ct.
0003069 Mar 02 Dollar General 200 ct.
0003071 Mar 02 Dollar General 200 ct.
0003074 Mar 02 Smart Choice 100 ct. coated
0003081 Mar 02 Medic 100 ct. Coated
0003093 Mar 02 Our Family 100 ct. Coated
0003094 Mar 02 Our Family 300 ct. Coated
0003095 Mar 02 Our Family 300 ct.
0003096 Mar 02 Our Family 500 ct. Coated
0003097 Mar 02 Snyder 500 ct. Coated
0003106 Mar 02
York 1,000 ct.
0003107 Mar 02 Snyder 1,000 ct. Coated
0003111 Mar 02 BULK COATED
0003112 Mar 02 Health Care 100 ct.
0003114 Mar 02 York 1,000 ct.
0003119 Mar 02 Our Family 500 ct. Coated
0003121 Mar 02 York 100
ct.
0004008 Mar 02 York 100 ct.
0004012 Mar 02 York 100 ct.
0004015 Mar 02 Dollar General 200 ct.
0004016 Mar 02 York 200 ct.
0004019 Mar 02 Navarro 200 ct. Coated
0004021 Mar 02 York 100 ct.
0004025 Mar 02 York 200 ct.
0004026 Mar 02 York 100 ct.
0004027 Mar 02 HyTop 250 ct.
0004031 Mar 02 Navarro 100 ct. Coated
0004034 Apr 02 Welby 200 ct. Coated
0004036 Apr 02 HyTop 250 ct.
0004037 Apr 02 Our Family 100 ct. Coated
0004038 Apr 02 Dollar General 200 ct.
0004040 Apr 02 Navarro 100 ct. Coated
0004050 Apr 02 Dollar General 200 ct.
0004051 Apr 02 HyTop 100 ct.
0004052 Apr 02 Parade 100 ct. Coated
0004062 Apr 02 Parade 100 ct. Coated
0004067 Apr 02 Our Family 300 ct. Coated
0004068 Apr 02 York 100 ct.
0004069 Apr 02 York 100 ct.
0004073 Apr 02
Welby 200 ct. Coated
0004079 Apr 02 York 100 ct.
0004087 Apr 02 Welby 200 ct. Coated
0004096 Apr 02 Vitatrade 1,000 ct.
0004097 Apr 02 Vi-Jon 100 ct.
0004098 Apr 02 Dollar General 200 ct.
0004099
Apr 02 Our Family 300 ct. Coated
0004103 Apr 02 Dollar General 200 ct.
0005005 Apr 02 DeMoulas 500 ct. Coated
0005009 Apr 02 Our Family 300 ct.
0005035 Apr 02 Vitatrade 1,000 ct.
0004095 May 02
Our Family 500 ct. Coated
0005015 May 02 DeMoulas 100 ct. Coated
0005017 May 02 Our Family 300 ct.
0005034 May 02 HyTop 100 ct.
0005039 May 02 Vitatrade 1,000 ct.
0005047 May 02 Vitatrade 1,000 ct.
0005051 May 02 Vitatrade 1,000 ct.
0005058 May 02 Vitatrade 1,000 ct.
0005060 May 02 Vitatrade 1,000 ct.
0005062 May 02 Vijon 100 ct. Coated
0005067 May 02 Dollar General 200 ct.
0005080 May 02
BULK COATED
0005083 May 02 Dollar General 200 ct.
0005092 May 02 Dollar General 200 ct.
0005093 May 02 HyTop 100 ct.
0005094 May 02 York 100 ct.
0005097 May 02 Our Family 500 ct. Coated
0005098 May 02 York 500 ct.
0005104 May 02 Our Family 500 ct. Coated
0005128 May 02 Dollar General 200 ct.
0006004 Jun 02 Dollar General 200 ct.
0006009 Jun 02 Our Family 300 ct.
0006011 Jun 02 York 200 ct.
0006020 Jun 02 Dollar General 200 ct.
0006025 Jun 02 Southern Home 100 ct. Coated
0006026 Jun 02 Dollar General 200 ct.
0006027 Jun 02 York 100 ct.
0006032 Jun 02 HyTop 100 ct.
0006044 Jun 02 York 200 ct.
0006050 Jun 02 York 200 ct. Coated
0006056 Jun 02 Smart Choice 100 ct. Coated
0006057 Jun 02 Our Family 100 ct. Coated
0006069 Jun 02 Quality Choice Coated
0006072 Jun 02 Smart Choice 100 ct. Coated
0006075 Jun 02 Smart Choice 100 ct. Coated
0006077 Jun 02 BULK ASPIRIN KG
0006082 Jun 02 Snyder 1,000 ct. Coated
0006087 Jun 02 Russian 100 ct.
0006090 Jun 02 Vitatrade 1,000 ct.
0006091 Jun 02 Dollar General 200 ct.
0006093 Jun 02 Vitatrade 1,000 ct.
0006094 Jun 02 Vitatrade 1,000 ct.
0006095 Jun 02 Dollar General 200 ct.
0006097 Jun 02 Welby 200 ct. Coated
0006098 Jun 02 Our Family 500 ct. Coated
0006099 Jun 02 Vitatrade 1,000 ct.
0006103 Jun 02 York 1,000 ct.
0006105 Jun 02 Vitatrade 1,000 ct.
0006109 Jun 02 Navarro 500 ct. Coated
0006110 Jun 02 Welby 200 ct. Coated
0006111 Jun 02 Vitatrade 1,000 ct.
0006112 Jun 02 Vitatrade 1,000 ct.
0006118 Jun 02 Dollar General 200 ct.
0007010 Jul 02 Navarro 250 ct. Coated
0007012 Jul 02 Dollar General 200 ct.
0007014 Jul 02 Russian 100 ct.
0007024 Jul 02 Russian 100 ct.
0007027 Jul 02 Russian 100 ct.
0007030 Jul 02 Russian 100 ct.
0007035 Jul 02 Russian 100 ct.
0008068 Aug 02 York 100 ct.
0008087 Aug 02 York 200 ct.
0012055 Dec 02 Dollar General 200 ct.
0012074 Dec 02 Health Care 200 ct.
REASON: Dissolution failures (starting at 2 months of
stability)
MANUFACTURER/RECALLING FIRM: York Pharmaceuticals,
Inc., Kansas City, KS
DISTRIBUTION: Nationwide
QUANTITY: Uncoated Tablet Btls: 100-ct.-640,368; 200
ct.-402,399; 250-ct.-40,104; 500-ct.-15,660; 1,000-ct.-69,060 Coated Tablet
Btls: - 100-ct.-324,720; 200-ct.-114,288; 250-ct.-23,904; 300-ct.-85,968;
500-ct.-36,984; 1,000-ct.-2,160; BULK COATED TABLETS - 4,050,000; and
1/1,994-kg. drum
PRODUCT AND CODE: OxyContin, (oxycodone
hydrochloride controlled-release) tablets, 10 mg. Rx Only, Dist. by Purdue
Pharma L.P., Norwalk, CT 06850,
Packaged in units of 25 and 100 tablets.
OxyContin,
(oxycodone hydrochloride controlled-release) tablets, 20 mg. Rx Only, Dist. by
Purdue Pharma L.P., Norwalk, CT 06850,
Packaged in units of 25 and 100 tablets.
OxyContin,
(oxycodone hydrochloride controlled-release) tablets, 40 mg. Rx Only, Dist. by
Purdue Pharma L.P., Norwalk, CT 06850,
Packaged in units of 25 and 100 tablets.
OxyContin,
(oxycodone hydrochloride controlled-release) tablets, 80 mg. Rx Only, Dist. by
Purdue Pharma L.P., Norwalk, CT 06850,
Packaged in units of 25 and 100 tablets.
OxyContin,
(oxycodone hydrochloride controlled-release) tablets, 160 mg. Rx Only, Dist. by
Purdue Pharma L.P., Norwalk, CT 06850,
Packaged
in units of 25 and 100 tablets.
There
are 388 batches of OxyContin, 10, 20, 40, 80, 160mg Tablets:
10
mg Tablets:
9L91, EXP 28-FEB-05
9M11, EXP 28-FEB-05
9M21, EXP 28-FEB-05
AE81, EXP 31-DEC-04
AE91, EXP 31-DEC-04
AF01, EXP 31-DEC-04
AF81, EXP 31-DEC-04
AF91, EXP 31-DEC-04
AG21, EXP 31-DEC-04
AH41, EXP 28-FEB-05
AH51, EXP 28-FEB-05
AH61, EXP 28-FEB-05
AJ61, EXP 31-JAN-05
AJ71, EXP 31-JAN-05
AJ81, EXP 31-JAN-05
AW81, EXP 31-JAN-05
AW91, EXP 31-JAN-05
AY01, EXP 28-FEB-05
AY11, EXP 28-FEB-05
AY21, EXP 28-FEB-05
AY31, EXP 28-FEB-05
AY41, EXP 28-FEB-05
AY51, EXP 28-FEB-05
AX01, EXP 31-JAN-05
AX04, EXP 31-JAN-05
2L61, EXP 30-NOV-03
2L71, EXP 31-DEC-03
2L81, EXP 31-DEC-03
2W11, EXP 31-DEC-03
2W21, EXP 31-DEC-03
2W31, EXP 31-DEC-03
2Y41, EXP 31-DEC-03
2Y61, EXP 31-DEC-03
2Y71, EXP 31-DEC-03
2Y81, EXP 31-DEC-03
3E51, EXP 31-DEC-03
3E61, EXP 31-JAN-04
CX51, EXP 30-APR-05
CX61, EXP 30-APR-05
WA431,
EXP 30-APR-05
WA561,
EXP 30-APR-05
WA571,
EXP 30-APR-05
8G21, EXP 31-OCT-04
8S1N1,
EXP 31-OCT-04
8S2N1,
EXP 30-NOV-04
8S9N1,
EXP 30-SEP-04
8T0N1,
EXP 30-SEP-04
8T1N1,
EXP 30-SEP-04
8X31, EXP 31-OCT-04
8X41, EXP 31-OCT-04
8X51, EXP 31-OCT-04
8X91, EXP 30-SEP-04
8Y01, EXP 30-SEP-04
8Y11, EXP 30-SEP-04
9E41, EXP 31-OCT-04
9E51, EXP 31-OCT-04
9E61, EXP 31-OCT-04
9E71, EXP 30-NOV-04
9E81, EXP 30-NOV-04
9K1N1,
EXP 31-OCT-04
9K3N1,
EXP 31-OCT-04
9P7N1,
EXP 30-NOV-04
9P8N1,
EXP 30-NOV-04
9P9N1,
EXP 30-NOV-04
9R4N1,
EXP 30-NOV-04
9R5N1,
EXP 30-NOV-04
9S5N1,
EXP 30-NOV-04
9S6N1,
EXP 30-NOV-04
9S7N1,
EXP 30-NOV-04
9V4N7,
EXP 30-NOV-04
9W2N1,
EXP 30-NOV-04
9E91, EXP 30-NOV-04
9R61, EXP 30-NOV-04
9R62, EXP 30-NOV-04
20mg
Tablets:
9R21, EXP 30-NOV-04
9W01, EXP 30-NOV-04
AD62, EXP 31-DEC-04
AD71, EXP 31-DEC-04
AD81, EXP 31-DEC-04
AF11, EXP 31-DEC-04
AF21, EXP 31-DEC-04
AF31, EXP 31-DEC-04
AG81, EXP 31-DEC-04
AG91, EXP 31-DEC-04
AH01, EXP 31-DEC-04
AJ01, EXP 31-DEC-04
AJ11, EXP 31-DEC-04
AJ21, EXP 31-DEC-04
AK21, EXP 31-JAN-05
AK31, EXP 31-JAN-05
AK41, EXP 31-JAN-05
AW51, EXP 31-JAN-05
AW61, EXP 31-JAN-05
AW71, EXP 31-JAN-05
AX31, EXP 31-JAN-05
AX41, EXP 31-JAN-05
BB1N1,
EXP 28-FEB-05
BB2N1,
EXP 28-FEB-05
BB3N1,
EXP 28-FEB-05
AX54, EXP 31-JAN-05
2L2N1,
EXP 31-DEC-03
2L3N1,
EXP 31-DEC-03
2L4N1,
EXP 31-DEC-03
2M11, EXP 30-NOV-03
2M2N2,
EXP 30-NOV-03
2M3N1,
EXP 30-NOV-03
2M4N2,
EXP 30-NOV-03
2M5N1,
EXP 31-DEC-03
2T91, EXP 31-DEC-03
2V01, EXP 31-DEC-03
2V11, EXP 31-DEC-03
2W41, EXP 31-DEC-03
2W51, EXP 31-DEC-03
2W61, EXP 31-DEC-03
2X41, EXP 31-DEC-03
2X51, EXP 31-DEC-03
2X61, EXP 31-JAN-04
2X71, EXP 31-DEC-03
2X72, EXP 31-DEC-03
2X81, EXP 31-DEC-03
2X91, EXP 31-DEC-03
2Y01, EXP 31-JAN-04
2Y11, EXP 31-JAN-04
BX71, EXP 30-APR-05
BX81, EXP 30-APR-05
BX91, EXP 30-APR-05
CR61, EXP 31-MAR 05
CR71, EXP 31-MAR-05
CR81, EXP 31-MAR-05
CR91, EXP 30-APR-05
CS01, EXP 30-APR-05
CS11, EXP 30-APR-05
CY11, EXP 30-APR-05
CY21, EXP 30-APR-05
CY31, EXP 30-APR-05
CY41, EXP 30-APR-05
CY51, EXP 30-APR-05
CY61, EXP 30-APR-05
CY71, EXP 30-APR-05
CY81, EXP 30-APR-05
CY91, EXP 30-APR-05
WA401,
EXP 30-APR-05
WA411,
EXP 30-APR-05
8R1N1,
EXP 31-0CT-04
8R2N1,
EXP 31-0CT-04
8R3N1,
EXP 31-0CT-04
8S31, EXP 31-OCT-04
8S41, EXP 31-OCT-04
8S51, EXP 31-OCT-04
8S61, EXP 31-OCT-04
8S71, EXP 30-NOV-04
8T21, EXP 30-SEP-04
8T31, EXP 30-SEP-04
8T41, EXP 30-SEP-04
8T51, EXP 30-SEP-04
8T61, EXP 30-SEP-04
8T7N1,
EXP 31-OCT-04
8T8N1,
EXP 30-NOV-04
8T9N1,
EXP 30-NOV-04
8X6N1,
EXP 30-NOV-04
8X71, EXP 31-OCT-04
8X81, EXP 30-NOV-04
9C31, EXP 31-0CT-04
9C41, EXP 31-OCT-04
9C51, EXP 31-0CT-04
9C91, EXP 31-OCT-04
9D01, EXP 31-OCT-04
9J51, EXP 31-OCT-04
9J61, EXP 31-OCT-04
9J71, EXP 31-OCT-04
9J8N1,
EXP 31-OCT-04
9J9N1,
EXP 31-OCT-04
9K0N1,
EXP 31-OCT-04
9L6N1,
EXP 30-NOV-04
9L7N1,
EXP 30-NOV-04
9L8N1,
EXP 30-NOV-04
9R0N1,
EXP 30-NOV-04
9R1N1,
EXP 30-NOV-04
9S1N7,
EXP 30-NOV-04
9S8N1,
EXP 30-NOV-04
9S9N1,
EXP 30-NOV-04
9T0N1,
EXP 30-NOV-04
9T7N1,
EXP 30-NOV-04
9T8N1,
EXP 30-NOV-04
9T9N1,
EXP 30-NOV-04
9D11, EXP 31-OCT-04
40mg
Tablets:
9L31, EXP 31-DEC-04
9V1N1,
EXP 30-NOV-04
9V2N1,
EXP 30-NOV-04
9V3N1,
EXP 30-NOV-04
9W11, EXP 31-DEC-04
AD91, EXP 31-DEC-04
AE01, EXP 31-DEC-04
AE11, EXP 31-DEC-04
AF41, EXP 31-DEC-04
AF51, EXP 31-DEC-04
AF61, EXP 31-DEC-04
AG51, EXP 31-DEC-04
AG61, EXP 31-DEC-04
AG71, EXP 31-DEC-04
AH11, EXP 31-DEC-04
AH21, EXP 31-DEC-04
AH31, EXP 31-DEC-04
AJ91, EXP 31-JAN-05
AX81, EXP 31-JAN-05
AX91, EXP 31-JAN-05
AY61, EXP 28-FEB-05
AY9N1,
EXP 31-JAN-05
BA0N1,
EXP 31-JAN-05
BA1N1,
EXP 28-FEB-05
BA2N1,
EXP 31-JAN-05
BA3N1,
EXP 31-JAN-05
BA4N1,
EXP 31-JAN-05
BD01, EXP 28-FEB-05
BD11, EXP 28-FEB-05
BD21, EXP 28-FEB-05
AK01, EXP 31-JAN-05
2M9N1,
EXP 31-DEC-03
2V21, EXP 31-DEC-03
2V31, EXP 31-DEC-03
2V41, EXP 31-DEC-03
2V81, EXP 31-DEC-03
2V91, EXP 31-DEC-03
2W01, EXP 31-DEC-03
2W71, EXP 31-DEC-03
2W81, EXP 31-DEC-03
2W91, EXP 31-JAN-04
CS21, EXP 30-APR-05
CS31, EXP 30-APR-05
CS41, EXP 30-APR-05
CS51, EXP 30-APR-05
CS61, EXP 30-APR-05
CS71, EXP 30-APR-05
8V0N1,
EXP 31-OCT-04
8V1N1,
EXP 31-OCT-04
8V2N1,
EXP 31-OCT-04
8V41, EXP 30-SEP-04
8V51, EXP 30-SEP-04
8V61, EXP 30-SEP-04
8V91, EXP 30-SEP-04
8W01, EXP 30-SEP-04
8W1N1,
EXP 31-OCT-04
8W41, EXP 30-SEP-04
8W51, EXP 31-OCT-04
8W61, EXP 31-OCT-04
8W71, EXP 31-OCT-04
8W81, EXP 31-OCT-04
8W91, EXP 31-OCT-04
9C01, EXP 31-OCT-04
9C11, EXP 31-OCT-04
9C21, EXP 31-OCT-04
9D51, EXP 31-OCT-04
9D61, EXP 31-OCT-04
9D71, EXP 31-OCT-04
9D81, EXP 31-OCT-04
9D91, EXP 31-OCT-04
9E01, EXP 31-OCT-04
9K41, EXP 31-OCT-04
9K51, EXP 31-OCT-04
9K61, EXP 31-OCT-04
9L0N1,
EXP 31-OCT-04
9L11, EXP 31-OCT-04
9L21, EXP 31-OCT-04
9L4N1,
EXP 30-NOV-04
9L5N1,
EXP 30-NOV-04
9R7N1,
EXP 30-NOV-04
9T1N1,
EXP 30-NOV-04
9T2N1,
EXP 30-NOV-04
9T3N5,
EXP 30-NOV-04
AX71, EXP 31-JAN-05
9D52, EXP 31-OCT-04
80mg
Tablets:
9T4N1,
EXP 30-NOV-04
9T5N1,
EXP 30-NOV-04
9T6N1,
EXP 30-NOV-04
9V8N1,
EXP 31-DEC-04
9V91, EXP 31-DEC-04
AE51, EXP 31-DEC-04
AE61, EXP 31-DEC-04
AE71, EXP 31-DEC-04
AF71, EXP 31-DEC-04
AG01, EXP 31-DEC-04
AG11, EXP 31-DEC-04
AH71, EXP 31-DEC-04
AH81, EXP 31-DEC-04
AH91, EXP 31-DEC-04
AJ31, EXP 31-DEC-04
AJ41, EXP 31-DEC-04
AJ51, EXP 31-JAN-05
AL11, EXP 31-JAN-05
AL21, EXP 31-JAN-05
AL31, EXP 31-JAN-05
AX61, EXP 28-FEB-05
BA51, EXP 28-FEB-05
BA61, EXP 28-FEB-05
BA71, EXP 28-FEB-05
BA81, EXP 28-FEB-05
AE52, EXP 31-DEC-04
2L5N1,
EXP 31-DEC-02
2V61, EXP 31-DEC-02
2V71, EXP 31-DEC-02
2X01, EXP 31-DEC-02
2X11, EXP 31-JAN-03
2X21, EXP 31-JAN-03
CK81, EXP 31-MAR-05
CK91, EXP 31-MAR-05
CL01, EXP 31-MAR-05
CL11, EXP 30-APR-05
WA581,
EXP 30-APR-05
WA591,
EXP 30-APR-05
WA601,
EXP 30-APR-05
8P8N1,
EXP 31-OCT-04
8P9N1,
EXP 31-OCT-04
8R0N1,
EXP 31-OCT-04
8V3N1,
EXP 31-OCT-04
8V71, EXP 30-SEP-04
8V81, EXP 30-SEP-04
8W2N1,
EXP 30-SEP-04
8W31, EXP 31-OCT-04
8X01, EXP 31-OCT-04
8X11, EXP 31-OCT-04
8X21, EXP 31-OCT-04
9C61, EXP 31-OCT-04
9C71, EXP 31-OCT-04
9C81, EXP 31-OCT-04
9D31, EXP 31-OCT-04
9D41, EXP 31-OCT-04
9E11, EXP 31-OCT-04
9E2N1,
EXP 31-OCT-04
9E3N1,
EXP 31-OCT-04
9K71, EXP 31-OCT-04
9K81, EXP 31-OCT-04
9K91, EXP 31-OCT-04
9S2N1,
EXP 30-NOV-04
9S3N1,
EXP 30-NOV-04
9S4N1,
EXP 30-NOV-04
160mg
Tablets:
9R31,
EXP 30-NOV-03
9V51,
EXP 30-NOV-03
9V61,
EXP 30-NOV-03
AG31,
EXP 31-DEC-03
AG41,
EXP 31-DEC-03
AX11,
EXP 31-JAN-04
AX21,
EXP 31-JAN-04
8S81,
EXP 30-SEP-03
9D21,
EXP 31-OCT-03
REASON: Contamination- tablets contain particles of
stainless steel and/or were manufactured with an unqualified excipient
MANUFACTURER/RECALLING FIRM: The P.F. Laboratories,
Inc., Totowa, NJ
RECALLED BY: Purdue Pharma L.P., Stamford, CT
DISTRIBUTION: Nationwide and Argentina, Bolivia, Brazil,
Central America, Mexico, Norway, and Peru
QUANTITY: 3,388,083 bottles of 100's and 257,797 blisters of
25
PRODUCT AND CODE: a) Sodium Bicarbonate
Injection, USP, 84 mg/mL, 50 mEq/50 mL, 50 mL single dose vial, NDC
#63323-006-50, product code 0650; For IV Use Only, Preservative Free
b)
Multi Vitamin Concentrate, 5 mL single dose vial, product code 4205; For IV
Infusion After Dilution
c)
Vinblastine Sulfate Injection, 1 mg/mL, 10 mL multiple dose vial, product code
27810; For IV Use Only
d)
Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL in 2 mL single
dose vial - NDC #63323-165-01, product code 16501 and 5 mL multiple dose vial,
product code 16505; For IM or IV Use
e)
Potassium Phosphates Injection, USP, Phosphorus 3 mM/mL and Potassium 4.4
mEq/mL, 50 mL single dose vial, product code 8650; For IV Use Only After
Dilution
f)
Potassium Acetate Injection, USP, 2 mEq/mL, 50 mL single dose vial, product
code 7650; For IV Use Only After Dilution
g)
Clindamycin Injection, USP, 150 mg/mL, 4 mL in 5 mL vial, product code C28204,
DIN 021 39286
h)
Sodium Chloride (Chlorure De Sodium) Injection, USP, 800 mmol/200 mL, 4
mmol/mL, 200 mL vial, DIN #02139510, product code
C88B2;
For intravenous infusion after diluation, Pharmacy Bulk Package, Not for Direct
Infusion
i)
Bacteriostatic Water for Injection, USP, 10 mL multiple dose vial, NDC
#63323-950-10, product code 95106; packaged with the Chorionic
Gonadotropin
for Injection and used to reconstitute the lyophilized powder
j)
Chorionic Gonadotropin for Injection, USP, 10,000 units/mL, 1 mL in 2 mL
multiple dose vial (lyophilized), NDC #63323-025-10, product
code
25021; For IM Use Only After Reconstitution
Codes:
a) Sodium Bicarbonate Injection, USP, lot 110660, exp. 01/03, lot 110670, exp.
01/03
b)
Multi Vitamin Concentrate, lot 110664, exp. 01/03
c)
Vinblastine Sulfate Injection, lot 110680, exp. 01/03
d)
Dexamethasone Sodium Phosphate Injection, USP, lot 110739, exp. 02/03, lot
110760, exp. 02/03, lot 110767, exp. 02/03
e) Potassium
Phosphates Injection, USP, lot 110754, exp. 08/04
f)
Potassium Acetate Injection, USP, lot 110766, exp. 02/04
g)
Clindamycin Injection, USP, lot 110652, exp. 01/03
h)
Sodium Chloride Injection, USP, lot 110710, exp. 02/03
i)
Bacteriostatic Water for Injection, USP, lot 110653, exp. 07/04
j)
Chorionic Gonadotropin for Injection, USP, lot 110645, exp. 07/03
REASON: Lack of assurance of sterility
MANUFACTURER/RECALLING FIRM: American Pharmaceutical
Partners, Inc., Melrose Park, IL
DISTRIBUTION: Nationwide and Canada
QUANTITY: 504471 vials
PRODUCT AND CODE: Zestril Tablets
(lisinopril), 10 mg, Rx, once-daily tablets, 100 tablets/bottle, Lot R2817, Exp. 02-03, NDC
0310-0131-10. Manufactured by IPR Pharmaceuticals,
Distributed by Zeneca Pharmaceuticals, Repackaged by Prestige Packaging.
Codes:
Lot R2817, Exp. 02-03
REASON: Mispackaging; Bottles labeled as 10 mg may contain
20 mg tablets
MANUFACTURER: IPR Pharmaceuticals,
Carolina, PR
RECALLED BY: Prestige Packaging Inc. Farmington Hills, MI
DISTRIBUTION: MI and OH
QUANTITY: 953 bottles distributed
PRODUCT AND CODE: 1.Burn relief spray
containing Benzocaine 5.0% and Benzalkonium chloride 0.14% packaged in 3-fl.
oz. containers, OTC. The product is
packaged under the following labels:
a. York Burn Relief with Aloe Vera
Antiseptic/Anesthetic, Manufactured by York Pharmaceuticals, Inc., Kansas City,
KS
b. Zee Burn Relief Spray with Aloe Vera,
Antiseptic/ Anesthetic, Manufactured for Zee Medical, Inc., Irvine, CA
c. Medi First Plus Pain Relieving Burn Spray
with Aloe Vera, Antiseptic Anesthetic, Packaged for Medi First Plus, Skokie, IL
d. Burn Relief with Aloe Vera Antiseptic,
Manufactured for First Aid Direct, Sunrise, FL
2.Antiseptic
Spray containing Lidocaine 2.5% and Benzalkonium chloride 0.14%, packaged in
3-fl. oz. containers, OTC. The product
is packaged under the following labels:
a. Zee First Aid Antiseptic Spray, Manufactured
for Zee Medical, Inc., Irvine, CA
b.
Medi First Plus Pain Relieving Antiseptic Spray, Packaged for Medi First Plus,
Skokie, IL
c. First Aid Antiseptic, Manufactured for First
Aid Direct, Sunrise, FL
d. First Aid Only Antiseptic Spray, Distributed
by First Aid Only, Inc., Vancouver, WA
e. Respond First Aid Antiseptic, Distributed by
Respond Industries, Inc., Denver, CO
Codes:
Burn Spray
Lot
# Exp. Date Label
0001123 Jan 02 Zee Medical
0008095 Aug 02 Zee Medical
0008096 Aug 02 Zee Medical
0009013 Sep 02 Zee Medical
0010004 Oct 02 First Aid Direct, Medi First, & Zee
0010005 Oct 02 First Aid Direct & Zee Medical
0011014 Nov 02 First Aid Direct & Zee Medical
0011037 Nov 02 York, First Aid Direct, Respond & Zee
0012017 Dec 02 Zee Medical
0101045 Jan 03 Zee Medical
0103017 Mar 03 York & Zee Medical
0103078 Mar 03 York & Zee Medical
Antiseptic
Spray
Lot
# Exp. Date Label
0001096 Jan 02 First Aid Only
0001133 Jan 02 Zee Medical
0002031 Feb 02 Zee Medical
0002046 Feb 02 Zee Medical
0002054 Feb 02 Zee Medical
0002057 Feb 02 Zee Medical
0002089 Feb 02 Zee Medical
0002090 Feb 02 First Aid Direct, First Aid Only & Zee
0003001 Mar 02 First Aid Only
0003010 Mar 02 First Aid Only
0003065 Mar 02 First Aid Only and Respond
0003092 Mar 02 First Aid Direct, First Aid Only &
Medi First
0004041 Apr 02 First Aid Only & Zee Medical
0005022 May 02 Zee Medical
0005023 May 02 Zee Medical
0005024 May 02 First Aid Only & Zee Medical
0005100 May 02 First Aid Only
0005111 May 02 First Aid Only
0006003 Jun 02 First Aid Only & Zee Medical
0006007 Jun 02 Zee Medical
0103079 Mar 03 Zee Medical
0104038 Mar 03 Zee Medical
0105006 Mar 03 Zee Medical
0105023 Mar 03 Zee Medical
REASON: Burn Relief Spray active ingredient Benozocaine is
super-potent --Antiseptic Spray active ingredient Lidocaine is sub-potent
MANUFACTURER/RECALLING FIRM: York Pharmaceuticals, Inc.
Kansas City, KS
DISTRIBUTION: NY, CA, FL, CO, IL, TN, GA,
and FL
QUANTITY: Burn spray - 105,996 bottles; antiseptic
spray - 247,596 btls
PRODUCT AND CODE: Colocort, Hydrocortisone
Enema,USP,(Retention)100 mg/60 ml, For Rectal Use Only, Rx only, disposable,
single-dose bottle, (one single 60 ml bottle in a box) and 0574-2020-07 (box of
seven 60 ml bottles of the product)
Codes:
Lot numbers 9M6024, 9M6049, 9M6051, 0C6226, 0C6230, 0E6338, OE6345, 0E6360,
0E6366, 0E6372, 0H6558, 421557, 431587, 441605, 441625, 481764, and 481782
REASON: Impurity specification failure at stability testing
(18 months)
MANUFACTURER/RECALLING FIRM: Paddock Laboratories, Inc.
Minneapolis, MN
DISTRIBUTION: Nationwide
QUANTITY: 230,000 bottles
PRODUCT AND CODE: Bronchial Mist, Epinephrine
Inhalation Aerosole USP,1/2 Fluid ounce (15 mL),5.5 mg/mL Epinephrine, plastic
coated glass vials packaged 1 per carton, 24/case. Packaged with actuator.
Codes: lot RD 1406 Exp 5/03
REASON: Dosage Uniformity Failure
MANUFACTURER/RECALLING FIRM: Armstrong Laboratories West
Roxbury, MA
RECALLED BY: Alpharma USPD Baltimore, MD
DISTRIBUTION: TN, IN, CT, KY, and RI
QUANTITY: 4608 unit doses
PRODUCT AND CODE: Hyoscyamine Sulfate, USP,
Extended Release Capsules, 0.375 mg, 100 capsule bottles, Rx only, NDC
51285-938-02.
Codes:
Lots 0024E, 0043E.
REASON: Sub-potency (9 month stability station)
MANUFACTURER/RECALLING FIRM: Carlsbad Technology, Inc.,
Carlsbad, CA
DISTRIBUTION: OH
QUANTITY: 800,000 capsules
PRODUCT Lantus Insulin Glargine (rDNA origin) Injection; 100
units/mL (U-100)in 10 mL vials, 10
vials per pack
CODE All lots of Lantus U-100 Insulin distributed to
Walgreens pharmacies between 5/2/01 and 9/7/01.
RECALLING FIRM/MANUFACTURER Recalling Firm: Walgreen
Co., Deerfield, IL
Manufacturer:
Aventis Pharma AG Frankfurt am Main, Germany.
REASON Temperature Abuse-product shipped unrefrigerated by
recalling firm.
VOLUME OF PRODUCT IN COMMERCE 38,000 vials.
DISTRIBUTION Nationwide.
PRODUCT Oxygen, USP, compressed, packaged in #2 high
pressure Cylinders,
CODE 12892001/11, 12892001/12, 12892001/13, 12892001/18,
12892001/20, 12902001/8, 12902001/12.
RECALLING FIRM/MANUFACTURER Nexair, LLC Memphis, TN
REASON Cylinders were contaminated with oil in and around
the valve threads.
VOLUME OF PRODUCT IN COMMERCE 22 cylinders.
DISTRIBUTION TN and AR.
PRODUCT Timoptic-XE (Timolol Maleate Ophthalmic Gel Forming
Solution) 0.5% Timolol Equivalent (Timolol Maleate 6.8 mg/mL), Rx only, 5 ml
Ophthalmic Dispenser
CODE Lot # 0304L exp. 12/02.
RECALLING FIRM/MANUFACTURER Merck & Co., Inc., West
Point, PA
REASON Lack of assurance of sterility.
VOLUME OF PRODUCT IN COMMERCE 74,671 units.
DISTRIBUTION Nationwide.
PRODUCT Fluocinolone Acetonide Topical Solution, USP, 0.01%,
For External Use Only, Not for Ophthalmic Use, Rx only,20 mL and 60
mL
plastic bottles.
The
Thames brand 20 mL bottle has a white and blue colored label, and is labeled in
part, "xxx NDC 49158-209-40 xxx FLUOCINOLONE ACETONIDE xxx SOLUTION xxx
USP, 0.01% xxx Rx only xxx 20 mL xxx Thames PHARMACAL CO., INC. xxx Ronkonkoma,
N.Y.
11779
USA xxx".
The
Thames brand 60 mL bottle is white and blue colored label, and is labeled in
part, "xxx NDC 49158-209-32 xxx FLUOCINOLONE
ACETONIDE
xxx SOLUTION USP, 0.01% xxx Rx only xxx 60 mL xxx Thames PHARMACAL CO., INC. xxx
Ronkonkoma, N.Y. 11779 USA xxx".
The
Qualitest brand 20 mL bottle has a brown and beige colored label, and is
labeled in part, "xxx NDC 0603-1231-43 xxx FLUOCINOLONE ACETONIDE xxx
TOPICAL SOLUTION USP, 0.01% xxx Mfg.
for: QUALITEST PHARMACEUTICALS, INC., xxx HUNTSVILLE, AL 35811
xxx
Rx only xxx NET CONTENTS 20 mL xxx Qualitest(R) xxx".
The
Qualitest brand 60 mL bottle has a brown and beige colored label, and is
labeled in part, "xxx NDC 0603-1231-49 xxx
FLUOCINOLONE
ACETONIDE xxx SOLUTION USP, 0.01% xxx Mfg. for: QUALITEST PHARMACEUTICALS,
INC., xxx HUNTSVILLE, AL 35811 xxx NET CONTENTS 60 mL xxx Qualitest(R)
xxx".
The
Schein Pharmaceutical brand 60-mL bottle has blue and white colored label, and
is labeled in part, “xxx SCHEIN PHARMACEUTICAL xxx NDC 0364-7343-58 xxx
FLUOCINOLONE ACETONIDE xxx Topical Solution, USP, xxx 0.01% xxx Mfd. for:
Schein Pharmaceutical, Inc. xxx Florham
Park, NJ 07932 USA xxx 60 mL xxx”.
The
Major Pharmaceuticals brand 60-mL bottle has a blue, red and green colored
label, and is labeled in part, “xxx NDC 0904-2661-03 xxx Fluocinolone Acetonide
xxx Topical Solution USP, xxx 0.01% xxx Rx only xxx 60 mL xxx MAJOR(R)
PHARMACEUTICALS xxx Distributed by Major Pharmaceuticals xxx Livonia, MI 48150
USA xxx”.
CODE Lots: N304 (exp. 7/2002), N409 (exp. 7/2002), N588
(exp. 12/2002), N660 (exp. 2/2003) Thames NDC: 49158-209-40 (20 mL),
49158-209-32 (60 mL)Qualitest NDC: 0603-1231-43 (20 mL), 0603- 1231-49 (60 mL)
Schein NDC: 0364-7343-58 (60 mL). Major NDC: 0904-2661-03 (60 mL).
PLEASE
NOTE: Schein Pharmaceutical labeled product in 20 mL bottles with NDC
0364-7343-55 listed in the 24 Hour Alert was not included
in
the RR as it was discovered that it had not been distributed.
RECALLING FIRM/MANUFACTURER Thames Pharmacal Co., Inc.
Ronkonkoma, NY
REASON Subpotency
(12 month stability).
VOLUME OF PRODUCT IN COMMERCE A total of 73,612 bottles:
37,696 - 20 mL bottles and 35,916 - 60 mL bottles.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT Chlor-Trimeton Allergy 8 hour tablets, Chlorphenirmaine
maleate, 8 mg per tablet, 15 tablets, blister packaged. The product
is
labeled in part:
Chlor-Trimeton
Antihistamine Allergy 8 Hour 15 tablets Schering-Plough HealthCare Products,
Inc. Memphis, TN. Inside each carton is a foil blister of fifteen (15) tablets
labeled in part: Chlor-Trimeton 8 Hour Allergy Tablets 7-CC-2 EXP 1/02
Schering-Plough HealthCare Products, Inc. Memphis, TN
CODE Lot No. 7-CC-2, Expiration January 2002.
RECALLING FIRM/MANUFACTURER Recalling Firm: Schering
Plough Healthcare Products, Cleveland, TN
Manufacturer:
Schering Laboratories Kenilworth, NJ.
REASON Dissolution Failure at 2 hour test time (Stability
50th month).
VOLUME OF PRODUCT IN COMMERCE 154,404.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT Atarax tablets (hydroxyzine HCl), 10 mg, 100 Tablet
bottles, Rx only, Pfizer Roerig, Division of Pfizer, Inc., NY, NY,
CODE Lot # 0105K00A, expiration date 7/2002, NDC
0049-5600-66, Item #4341.
RECALLING FIRM/MANUFACTURER Recalling Firm: Pfizer, Inc.
New York, NY Manufacturer: Pfizer, Inc. Brooklyn, NY.
REASON Dissolution failure (12th month stability).
VOLUME OF PRODUCT IN COMMERCE 24,140 bottles were
distributed.
DISTRIBUTION Nationwide and Puerto Rico, Trinidad, Bahamas
and St. Marten.
PRODUCT a) BETCO brand Premium Antibacterial Hand Cleaner
with Aloe (catalog #73644) - Active Ingredient - Chloroxylenol 0.5%,
The
recalled products are packed and distributed in the following size/type
containers: Premium Antibacterial Hand Cleaner (#73644):
55-gallon
drums; sold individually; 5-gallon pails; sold individually; 1-gallon
containers; 4 per case; 16 oz bottles; 12 per case; 8 oz bottles; 12 per case;
4 oz bottles; 24 per case; 1100 ml Bag-In-Box; 10 per case; 900 ml Bag-In-Box;
12 per case; 500 ml Bag-In-Box; 18 per case
b)
BETCO brand Winning Hands Pearlized Antiseptic Lotion Hand Cleaner (catalog
#14104) - Active Ingredient - Chloroxylenol
0.375%,
Winning Hands Pearlized Antiseptic Lotion Hand Cleaner (#14104): 55-gallon
drums; sold individually; 5-gallon pails; sold individually; 1-gallon
containers; 4 per case; 4 oz bottles; 24 per case; 1100 ml Bag-In-Box; 10 per
case; 900 ml Bag-In-Box; 12 per case;
500
ml Bag-In-Box; 18 per case
CODE a) Premium Antibacterial Hand Cleaner with Aloe
(#73644): Lot Numbers: 2690, 2770, 2850, 2980, 3010, 3080, 3210, 3320, 3410,
3460, 3540, 0041, 0521, 0651, 0781, 0871, 0941, 1011, 1161, 1211, 1281, 1371,
1431, 1571, 1601, 1691, 1761, 1901, 1931, 1971, 2061, 2071, 2131, 2201, 2291,
2351, 2491, 2531, 2571, 2611.
Expiration
Dates: 9/25/2001, 10/3/2001, 10/11/2001, 10/24/2001, 10/27/2001, 11/3/2001,
11/16/2001, 11/27/2001, 12/6/2001, 12/11/2001, 12/19/2001, 1/4/2002, 1/9/2002,
1/16/2002, 1/25/2002, 1/31/2002, 2/10/2002, 2/21/2002, 3/6/2002, 3/19/2002,
3/28/2002, 4/4/2002, 4/11/2002,
4/26/2002, 5/1/2002, 5/8/2002, 5/17/2002, 5/23/2002, 6/6/2002, 6/9/2002,
6/18/2002, 6/25/2002, 7/9/2002, 7/12/2002, 7/16/2002, 7/25/2002, 7/26/2002,
8/1/2002, 8/8/2002, 8/17/2002, 8/23/2002, 9/6/2002, 9/10/2002, 9/14/2002, 9/18/2002.
b)
Winning Hands Pearlized Antiseptic Lotion Hand Cleaner (#14104): Lot Numbers:
2710, 2770, 2920, 2990, 3040, 3140, 3220, 3340, 3400, 3490, 3560, 0041, 0111,
0221, 0241, 0321, 0441, 0471, 0591, 0671, 0791, 0861, 0931, 0991, 1131, 1231,
1291, 1421, 1561, 1591, 1691, 1721, 1801, 1871, 1941, 2041, 2081, 2191, 2251,
2281, 2331, 2411, 2491, 2571, 2641.
Expiration
dates: 9/28/2001, 10/3/2001, 10/18/2001, 10/25/2001, 10/30/2001,11/9/2001,
11/17/2001, 11/29/2001, 12/5/2001, 12/14/2001, 12/21/2001, 1/4/2002, 1/11/2002,
1/22/2002, 1/24/2002, 2/1/2002, 2/13/2002, 2/16/2002, 2/28/2002, 3/8/2002,
3/20/2002, 3/27/2002, 4/3/2002, 4/9/2002, 4/23/2002, 5/3/2002, 5/9/2002,
5/22/2002, 6/5/2002, 6/8/2002, 6/18/2002, 6/21/2002, 6/29/2002, 7/6/2002,
7/13/2002, 7/23/2002, 7/27/2002, 8/7/2002,
8/13/2002,
8/16/2002, 8/21/2002, 8/29/2002,
9/6/2002, 9/14/2002, 9/21/2002.
RECALLING FIRM/MANUFACTURER BETCO Corporation Toledo, OH
REASON Unapproved dye in products.
VOLUME OF PRODUCT IN COMMERCE a) Antibacterial HC - 43,
225 -gals total = all pkg. sizes and configurations
b)
Antiseptic HC - 123,000 gals total - all pkg. sizes and configurations.
DISTRIBUTION Nationwide and Japan, British Columbia.
PRODUCT Cheratussin AC Expectorant Cough Suppressant, Sugar
Free containing Guaifenesin, USP (100mg/5mL), Codeine Phosphate, USP
(10mg/5mL), and Alcohol, 3.5%. The product is manufactured under three names:
Qualitest, Vintage, and Zenith: Goldline (Zenith Goldline uses the name,
Guaituss AC Syrup, in place of Cheratussin),
CODE
Codes: Qualitest®
Lot
Number Suffix
012J9 A
012J9 B
012J9 C
017K9 A
018K9 A
005L9 B
005L9 C
005L9 D
006L9 A
038M9 A
039M9 A
039M9 C
039M9 D
011B0 A
012B0 A
012B0 F
003A0 B
004A0 B
004A0 C
004A0 D
023F0 B
008G0 A
008G0 B
008G0 D
012H0 C
012H0 D
012H0 E
045J0 A
046K0 A
046K0 C
046K0 D
002L0 A
016M0 A
019M0 A
019M0 C
043M0 B
043M0 C
043M0 E
024A1 D
062A1 B
062A1 C
062A1 E
062A1 F
036B1 A
036B1 C
037B1 A
059B1 A
023F1 A
027G1 A
Vintage®
Lot
Number Suffix
011B0 B
012B0 B
012B0 E
012B0 G
003A0 C
008G0 C
008G0 E
012H0 A
012H0 B
024A1 A
024A1 C
044D1 A
044D1 B
012F1 A
Zenith
Goldline
Lot
Number Suffix
018K9 B
005L9 A
039M9 B
011B0 C
012B0 C
012B0 D
003A0 A
004A0 A
023F0 A
046K0 B
046K0 E
043M0 A
043M0 D
024A1 B
062A1 B
036B1 B
059B1 B
007E1 A
007E1 B
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals,
Inc. Huntsville, AL
REASON Subpotency
(Codeine Phosphate ingredient at 12 month stability).
VOLUME OF PRODUCT IN COMMERCE 15,860,150 ounces.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT Premarin Tablets (conjugated estrogen tablets USP),
1.25 mg,100 tablets per bottle, Repackaged by National PharmPak Services,
Inc.,
Zanesville, OH, Rx only, Wyeth-Ayerst
CODE Lot No. 9010249B, Exp. Date 09/03.
RECALLING FIRM/MANUFACTURER Recalling Firm: National Pharmpak Services, Inc.,
Zanesville, OH
Manufacturer:
Ayerst Laboratories, Rouses Point, NY.
REASON Dissolution failure (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE 9851 bottles of 100 count.
DISTRIBUTION Nationwide
WEEK
ENDING NOVEMBER 24
PRODUCT Meperidine Hydrochloride Injection, USP 10 mg/mL, 30
mL (PCA Vial) NDC 0074-46030-04, Rx only.
CODE
Lot
Numbers and Exp. Dates.
69-226
DK, 01 APR 2002;
72-515
DK, 01 JUL 2002;
72-389
DK, 01 JUL 2002;
73-117
DK, 01 AUG 2002;
73-279
DK, 01 AUG 2002;
74-609
DK, 01 SEP 2002;
74-395
DK, 01 SEP 2002;
75-220
DK, 01 OCT 2002;
76-402
DK, 01 NOV 2002.
RECALLING FIRM/ MANFACTURER Abbott Laboratories Rocky
Mount, NC
REASON Mislabeling; Vial label has the numeric graduations
for volume (mL) and dosage (mg) transposed relative to the legend titles.
PRODUCT 712,950 units
DISTRIBUTION Nationwide.
PRODUCT Oxygen, USP, Compressed, in cylinder sizes of E, D,
M6, M9, and M12, Rx only
CODE Cylinders filled on 8/10/01, 8/11/01, 8/13/01, and
8/14/01. Lot numbers are:
2-H-10-V-1
- Size E, D, and M6; 2-H-10-V-2 - Size E and M6; 2-H-10-V-3 - Size E, D, and
M6; 2-H-10-V-4 - Size M6; 2-H-11-V-1 - Size E;
2-H-13-V-1
- Size E; 2-H-13-V-2 - Size E and D; 2-H-13-V-4 - Size E, D, M12, M9, and M6;
2-H-14-V-1 - Size E.
RECALLING FIRM/ MANFACTURER Island Supply Welding Co.
Norfolk, NE
REASON CGMP Deviations, including but not limited to
improper cleaning, and filling of high pressure cylinders and calibration of
assay equipment.
PRODUCT Size E - 100 or 101 (firm is checking to determine
the discrepancy); Size D - 26; Size M12 - 2; Size M9 - 1; Size M6 - 59.
DISTRIBUTION
NE
PRODUCT Product: CVP Antacid Anti-Gas Liquid with
Simethicone, 12 Fl. Oz. Distributed by Consumer Value Products, Inc. Temple, TX
CODE Lot 003018.
RECALLING FIRM/ MANFACTURER Recalling Firm: Chemrich Holdings, Inc., Los Angeles, CA
Manufacturer:
York Pharmaceuticals, Inc. Kansas City, KS.
REASON Batch failure for Total Aerobic Microbial Count specification
(at manufacturer.)
PRODUCT 5,352.
DISTRIBUTION TX and CO.
PRODUCT Estratest Tablets (Esterified Estrogen 1.25mg and
Methyltestosterone 2.5mg), Bottles of 100, NDC # 0032-1026-01, Rx only.
CODE Lot 91666, exp. November 2002.
RECALLING FIRM/ MANFACTURER Recalling Firm: Solvay
Pharmaceuticals, Inc. Marietta, GA.
Manufacturer:
Solvay Pharmaceuticals, Inc. Baudette, MN.
REASON Mis-Labeling -bottles may contain Estratest HS
tablets (half strength of both active ingredients).
PRODUCT 17,315 bottles
DISTRIBUTION Nationwide.
PRODUCT Allegra (fexofenadine hydrochloride) Tablets,
60-mg., 100-ct. bottles packaged in
24-bottle shipping containers, RX.
The
responsible firm on the label is Aventis Pharmaceuticals Inc., Kansas City, MO.
CODE 1038818, Exp. Dec. 27, 2003; 1039714, Exp. Feb. 6,
2004; 1039715, Exp. Feb. 6, 2004.
RECALLING FIRM/ MANFACTURER Aventis Pharmaceuticals,
Inc. Kansas City, MO
REASON Mis-labeling - Shipping carton bears incorrect NDC
Bar Code.
PRODUCT 30,681/100-ct. bottles (1,278 shipping cartons)
DISTRIBUTION Nationwide.