AUGUST 2002
WEEK ENDING AUGUST 3
PRODUCT Acyclovir Tablets, USP, 400 mg, Rx Only,100-count
bottles, Manufactured by: IVAX Pharmaceuticals, Miami, FL 33137,
CODE Lot No. 106091A
Exp. date Mar 04.
RECALLING FIRM/MANUFACTURER Recalling Firm: Ivax
Pharmaceuticals, Inc., Miami, FL
Manufacturer:
Ivax Pharmaceuticals Caribe, Inc., Cidra, Puerto Rico.
REASON Tablet crumbling.
VOLUME OF PRODUCT IN COMMERCE 11, 483 bottles.
DISTRIBUTION Nationwide.
PRODUCT a) Luvox (Fluvoxamine Maleate) Tablets (scored), 25
mg, 100 count bottles and unit dose packages of 100, Rx Only;
b)
Luvox (Fluvoxamine Maleate) Tablets (scored), 50 mg, 100 count bottles and unit
dose packages of 100, Rx Only;
c)
Luvox (Fluvoxamine Maleate) Tablets (scored), 100 mg, 100 count bottles and
unit dose packages of 100, Rx Only.
CODE a)LUVOX 25mg
- Lots 90645, 90646, 91001, 91338, 91375, 91721, 92032, 92038;
b)
LUVOX 50mg - Lots 90576, 90610, 90611,
90612, 90613, 90614, 90615, 90644, 90731, 90733, 90734, 90735, 90736, 90737,
90841, 90842, 90843, 90844, 90845, 90846, 90996, 90997, 90998, 90999, 91000,
91229, 91230, 91232, 91233, 91234, 91235, 91236, 91237, 91320, 91321, 91322,
91323, 91376, 91377, 91378, 91379, 91380, 91543, 91544, 91617, 91618, 91619,
91620, 91621, 91646, 91653, 92094, 92165;
c)
LUVOX 100mg - Lots 90410, 90411, 90414, 90415, 90454, 90455,
90456, 90457, 90555, 90556, 90557, 90558, 90559, 90560, 90561, 90562, 90563,
90564, 90699, 90700, 90701, 90702, 90703, 90704, 90705, 90713, 90714, 90715,
90716, 90717, 90718, 90719, 90720, 90721, 90722, 90831, 90832, 90833, 90834,
90835, 90836, 90837, 90838, 90849, 90850, 90851, 90852, 90853, 90854, 90855,
90856, 90857, 90858, 90865, 90866, 90867, 90868, 90869, 90870, 90931, 90932,
90933, 90934, 90935, 90936, 91003, 91004, 91005, 91006, 91007, 91008, 91009,
91010, 91011, 91112, 91113, 91114, 91115, 91116, 91117, 91118, 91119, 91120,
91238, 91240, 91241, 91242, 91243, 91244, 91245, 91246, 91247, 91289, 91290,
91291, 91292, 91294, 91295, 91296, 91297, 91315, 91316, 91317, 91324, 91325,
91326, 91327, 91328, 91329, 91330, 91331, 91364, 91365, 91366, 91367, 91368,
91369, 91370, 91371, 91372, 91373, 91374, 91384, 91385, 91386, 91387, 91388,
91389, 91390, 91391, 91392, 91393, 91394, 91395, 91396, 91397, 91398, 91399,
91535, 91536, 91537, 91538, 91539, 91540, 91541, 91542, 91610, 91611, 91645,
91647, 91648, 91649, 91650, 91651, 91652, 91658, 92091, 92092, 92093, 92113,
92114, 92115, 92116, 92117, 92118, 92119, 92120, 92121, 92163.
RECALLING FIRM/MANUFACTURER Recalling Firm: Solvay
Pharmaceuticals, Inc., Marietta, GA.
Manufacturer:
Solvay Pharmaceuticals, Inc., Baudette, MN.
REASON Inaccuracies in data submitted to the New Drug
Application by Solvay(stability).
VOLUME OF PRODUCT IN COMMERCE 1,503,114 units.
DISTRIBUTION Nationwide.
WEEK ENDING AUGUST 10
PRODUCT Levothroid Tablets (levothyroxine sodium tablets,
USP), 100 mcg., 100-tablet bottles, Rx only.
CODE Lot #16828, Exp. Aug 02, and Lot #17145, Exp. Sep
02.
RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource
Health Services Corp., Columbus, OH
Manufacturer:
Forest Pharmaceuticals, Inc, Cincinnati, OH.
REASON Stability; low potency prior to labeled expiration
date from manufacturer (Forest).
VOLUME OF PRODUCT IN COMMERCE 1,006 bottles.
DISTRIBUTION Nationwide.
PRODUCT RA SPES Capsules, Joint and Tendon Formula, 30
Capsules, 300 mg each, Herbal Dietary Supplement
OA
PLUS Capsules, Joint and Tendon Formula, 30 capsules, 300 mg each, Herbal
Dietary Supplement
HEPASTAT
Capsules, Liver Formula, 90 capsules, 300 mg each, Herbal Dietary Supplement
NEUTRALIS
Capsules, Immune System Formula, 30 capsules, 300 mg each, Herbal Dietary
Supplement
OSPORO
Capsules, Skeletal Formula, 30 Capsules, 300 mg each, Herbal Dietary Supplement
POENA
Capsules, Muscle and Tissue Formula, 30 capsules, 300 mg each, Herbal Dietary
Supplement
ARTHRIN
Capsules, Joint and Tendon Formula, 30 capsules, 300 mg each, Herbal Dietary
Supplement
CODE All codes.
RECALLING FIRM/MANUFACTURER Botanic Lab, Brea, CA
REASON Products contain various amounts and combinations of
undeclared prescription drug ingredients-Alprazolam, Indomethacin, Ethinyl
Estradiol, and/or DES.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide and Internationally.
PRODUCT Quinaglute Dura-Tabs, Extended Release Tablets (quinidine
gluconate, USP) 324 mg, 100, 250, and 500 count bottles, Rx.
CODE Lot Numbers:
W00238 Exp. 11/2004
W00239 Exp. 12/2004
W00240 Exp. 1/2005
W10001 Exp. 3/2005
W10028 Exp. 4/2005
W10029 Exp. 5/2005
W10111 Exp. 7/2005.
RECALLING FIRM/MANUFACTURER Berlex Laboratories, Inc.,
Wayne, NJ
REASON Metal particles in tablets.
VOLUME OF PRODUCT IN COMMERCE 2,603 bottles of 100's;
3,358 bottles of 250's; 15,286 bottles of 500's.
DISTRIBUTION Nationwide.
PRODUCT Premarin Tablets (conjugated estrogens tablets, USP)
1.25 mg, 1,000 count bottles, Rx only.
CODE Lot #15570, Exp. 08/08/02.
RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource
Health Services Corp., Columbus, OH
Manufacturer:
Ayerst Laboratories, Inc., Rouses Point, NY.
REASON Failure to meet USP dissolution specifications by
manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE 239 bottles.
DISTRIBUTION OH, NJ, KY, AL, MO, ID, TX, VA, FL, and NC.
PRODUCT Premarin Tablets (conjugated estrogens tablets,
USP), 1.25 mg,100 tablet bottles, Rx only.
CODE Lot #9000481D, Exp. 01/05.
RECALLING FIRM/MANUFACTURER Recalling Firm: National
Pharmpak Services, Inc., Zanesville, OH
Manufacturer:
Ayerst Laboratories, Inc., Rouses Point, NY.
REASON Failure to meet USP dissolution specifications by
manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE 9,601 bottles.
DISTRIBUTION Nationwide.
PRODUCT Desyrel Tablets (Trazodone HCL), 100 mg, 100 count
bottles, Rx only.
CODE Lot #011751, Exp. Nov 02, and Lot #012056, Exp. Aug
03.
RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource
Health Services Corp., Columbus, OH
Manufacturer:
Mead Johnson Pharmaceuticals, Evansville, IN.
REASON Lack of uniformity of dosage-subpotent tablets (stability
18 month) by manufacturer-Mead Johnson Pharmaceuticals A Bristol Myers Squibb
Co.
VOLUME OF PRODUCT IN COMMERCE 646 bottles.
DISTRIBUTION Nationwide.
PRODUCT Glucagon Kit, Glucagon for Injection, USP TROUSSE DE
GLUCAGON, 1 mg (1 unit)/vial (with 49 mg Lactose)
(Product
#M-8239, DIN 00015377).
CODE Lots 4ND49M (exp. 12/1/02) and 4ND49N (exp. 3/1/03).
RECALLING FIRM/MANUFACTURER Eli Lilly and Co.,
Indianapolis, IN
REASON Subpotent-out of specification result at 12 month time
point for potency (the rat hepatocyte test).
VOLUME OF PRODUCT IN COMMERCE 34,028 UNITS (Lot 4ND49M) and 24,835 UNITS (LOT 4ND49N).
DISTRIBUTION Canada.
PRODUCT Depo-Provera Contraceptive Injection
(medroxyprogesterone acetate injectable suspension, USP), 150 mg/ml,
Single-Dose Vial, For intramuscular use only, one 1ml vial, Rx Only.
CODE Lot 79HWX, Exp. Date 4/06.
RECALLING FIRM/MANUFACTURER Pharmacia Corp., Kalamazoo,
MI
REASON May contain particles of inert polymeric material
from a pumping hose.
VOLUME OF PRODUCT IN COMMERCE 14,653 units.
DISTRIBUTION Nationwide.
PRODUCT Gentle Lubricant Eye Drops, Sterile, 1 FL. OZ. (30
mL) plastic Bottles.
This
OTC product was distributed under the following labels:
-
Sav-on Osco by Albertson’s(TM) Gentle Lubricant Eye Drops, Sterile, NDC
41163-951-30.
-
Equate(R) sterile gentle lubricant eye drops, 1 FL OZ (30 mL), NDC
54799-951-30.
CODE Lot number 10309, expiration date 10/03 Equate
brand: NDC # 54799-951-30, barcode # 15718 95130
Sav-on
Osco brand: NDC# 411163-951-30, barcode # 41163 25390.
RECALLING FIRM/MANUFACTURER Altaire Pharmaceuticals,
Inc., Aquebogue, NY
REASON Subpotent (by manufacturer).
VOLUME OF PRODUCT IN COMMERCE 11,312 bottles distributed.
DISTRIBUTION OR, AZ, GA, MI, PA, AR, MS, TX and AL.
WEEK
ENDING AUGUST 17
PRODUCT a) Clonazepam Tablets, USP 1
mg, 100, 500, and 1,000 count bottles, Rx only;
b) Clonazepam Tablets, USP 2
mg, 100 and 500 count bottles, Rx only.
CODE a) Lot numbers for 1 mg
strength: 356546 exp. 11/30/03, 356547
exp. 11/30/03, 356548 exp. 11/30/03, 356549 exp. 11/30/03, 356550 exp.
11/30/03, 356551 exp. 11/30/03, 356552 exp. 11/30/03, 356553 exp. 11/30/03,
356554 exp. 11/30/03, 356555 exp. 11/30/03, 356556 exp. 11/30/03, 356557 exp. 11/30/03,
356558 exp. 11/30/03, 356559 exp. 11/30/03, 356560 exp. 11/30/03, 356561 exp.
11/30/03, 356562 exp. 11/30/03, 356563 exp. 11/30/03, 356564 exp. 11/30/03, and
356565 exp. 11/30/03.
b) Lot numbers for 2 mg
strength: 355108 exp. 11/30/03, 355109
exp. 11/30/03, and 355110 exp. 11/30/03.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Teva
Pharmaceuticals USA, Sellersville, PA
Manufacturer: Teva Pharmaceuticals, Jerusalem, Israel.
REASON Tablet mix up: 2 mg tablets
may be in bottles labeled as containing 1 mg tablets and/or 1 mg tablets may be
in bottles labeled as containing 2mg tablets.
VOLUME OF
PRODUCT IN COMMERCE 160,391 bottles.
DISTRIBUTION
Nationwide.
PRODUCT a) Levothroid Tablets
(levothyroxine sodium tablets, USP), 100-mcg, 100-count and 5,000-count
bottles.
b) Levothroid Tablets
(levothyroxine sodium tablets, USP), 125-mcg, 100-count bottles.
CODE a) 125 mcg. - Lot 70035,
Exp. 07/2002, 100-count
Lot 70038, Exp. 07/2002, 100-count
Lot 80033, Exp. 08/2002, 100-count
Lot 80034,
Exp. 08/2002, 100 count
b) 100 mcg. - Lot 80017,
Exp. 08/2002, 5,000 count
Lot 80019, Exp. 08/2002, 5,000 count
Lot 90014, Exp. 09/2002, 5,000 count
Lot 120028, Exp. 01/2003, 100 count.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Forest
Pharmaceuticals, Inc., St. Louis, MO
Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati,
OH.
REASON Subpotent prior to
expiration date.
VOLUME OF
PRODUCT IN COMMERCE 790/5,000-tab. btls; 64,637/100-tab. btls.
DISTRIBUTION
Nationwide.
PRODUCT Lariam (mefloquine HCl)
Tablets, 250mg, 25 carton count.
CODE B1023-50 exp. 12/2003;
B1024, exp. 12/2003; B1025, exp. 12/2003.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Roche
Laboratories, Nutley, NJ.
Manufacturer: F. Hoffmann-La Roche, Basel, Switzerland.
REASON Potential cross
contamination with active ingredients which could include levodopa/benserazide,
and/or sulfamethoxazole.
VOLUME OF
PRODUCT IN COMMERCE 69,447 bottles.
DISTRIBUTION
Nationwide
PRODUCT Imodium Advanced Chewable
Tablets (Loperamide HCL/Simethicone), single pack for display hanger, 2 tablets
per pack. Packaged in the clear pouch of the display hanger card is a viewable
single packet labeled Imodium A-D ANTI-DIARRHEAL (Loperamide HCl) Caplets, 2
CAPLETS Each caplet contains 2 mg loperamide HCl.
CODE Lot Numbers DFC049 and
DEC051.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Navajo
Manufacturing Company, Inc., Denver, CO
Manufacturer: McNeil Consumer Products, Fort Washington,
PA.
REASON Mispackaging by repacking
firm; Imodium A-D Caplets containing
Loperamide HCl were mislabeled as Imodium Advanced chewable tablets
containing Loperamide and Simethicone.
VOLUME OF
PRODUCT IN COMMERCE 51 / 2500 ct. cases.
DISTRIBUTION
Nationwide.
PRODUCT Cortizone 10 Anti-Itch
Ointment, 1% Hydrocortisone, 30% Bonus Size, 1.3 oz tube.
CODE Open Stock -- Lot 2499604.
Floor Display -- Lot 1899031
(this lot identifies the display lot where Lot 2499604 is packaged within).
RECALLING
FIRM/MANUFACTURER Recalling Firm: Pfizer Consumer
Healthcare, Morris Plains, NJ
Manufacturer: Pfizer Inc., Parsippany, NJ.
REASON Superpotency (24 month
stability test point).
VOLUME OF
PRODUCT IN COMMERCE Open stock -- 28,956; part of display -- 81,672.
DISTRIBUTION
Nationwide
PRODUCT North Burn Jel Topical
Analgesic: Contains Lidocaine HCL (2.0%) Six-Packets 1/8 oz. (3.5 g).
CODE Lot Number: M1G0407 Expiration Date: 01/04.
RECALLING
FIRM/MANUFACTURER Recalling Firm: North Safety
Products, Cranston, RI.
Manufacturer: North Safety Products, Mexacli, BC.
REASON Misbranding: Six unit
holding carton mislabeled as Burn Jel (Lidocaine HCl) but actually contains
individual non-medicated packages of the product Cool Jel.
VOLUME OF
PRODUCT IN COMMERCE 1,200 units.
DISTRIBUTION
AZ,
CA, CO, IL, OH, PA, FL, SC, MT, NV, WY and TX.
PRODUCT a) Hydrocortisone Cream 1%,
0.9 gram and 1 gram packets;
b) Hydrocortisone Cream .5%,
0.9 gram and 1 gram packets.
These over-the-counter drugs
are sold under the following private labels:
Hydrocortisone Cream USP 1%,
0.9 gram
Manufactured for Just
American Safety, Osceola, IN
1% Hydrocortisone Anti-Itch
Cream, 0.9 gram
Manufactured for First Aid
Direct, Sunrise, FL
Hydrocortisone Cream 1%
Manufactured for Textilease
Medique, Skokie, IL
Hydro-Max 1% Hydrocortisone
Acetate Cream, 0.9 gm
Manufactured for: AFFIRMED
MEDICAL INC., Dallas, TX
Hydrocortisone 1%, 0.9 gm
Manufactured for: ESAFETYCO,
Salinas, CA
SWIFT Hydrocortisone Cream
USP 1% packets, 1 gm
Dist. by Swift FIRST AID,
INC., Valencia, CA
Hydrocortisone Cream, 1/2%
and 1%, 1 gm
Distributed by: Moore Medical Corp., New Britian, CT
1/2% NDC #0839-8019-72 and 1% NDC #0839-8020-72
Hydrocortisone 1%, 0.9 gm
Mfg. for American First Aid,
Hanover, MD
Hydrocortisone Cream 1%, 1 gm
Dist. by Green Guard First
Aid and Safety Service, St. Louis, MO
Respond Hydrocortisone 1%
Cream Itch Relief, 1 gm
Manufactured for: Respond
Ind., Denver, CO.
CODE 1/2% cream lot numbers:
2238, Exp. 10/02 K-2380, Exp.
6/03 A-K-2445, Exp. 10/03
1% cream lot numbers:
A-K-2331, EXP. 9/02
A-K-2237, EXP. 10/02
A-K-2247, EXP. 11/02
A-K-2251, EXP. 12/02
A-K-2253, EXP. 12/02
A-K-2299, EXP. 1/03
A-K-2318, EXP. 2/03
A-K-2322, EXP. 3/03
A-K-2377, EXP. 5/03
A-K-2380, EXP. 6/03
A-K-2411, EXP. 7/03
A-K-2426, EXP. 9/03
A-K-2468, EXP. 11/03
A-K-2481, EXP. 12/03
A-K-2536, EXP. 2/04
A-K-2578, Exp. 2/04
K-2237, EXP. 10/02
K-2238, EXP. 10/02
K-2247, EXP. 11/02
K-2251, EXP. 12/02
K-2299, EXP. 1/03
K-2322, EXP. 3/03
K-2380, EXP. 6/03
K-2419, EXP. 8/03
247, EXP. 11/02.
RECALLING
FIRM/MANUFACTURER Recalling Firm: Ultraseal Corp., New Paltz, NY.
Manufacturer: Ultratab
Laboratories, Inc., Highland, NY.
REASON Subpotent.
VOLUME OF
PRODUCT IN COMMERCE 1/2% - 622,944 packets; 1 % - 786,416 packets.
DISTRIBUTION
CA,
CO, FL, IL, KS, MD, and MO.
PRODUCT
Premarin (conjugated estrogen tablets USP). 1.25 mg tablets,1000 and
5,000-tablet bottles.
CODE NDC #:
0046-0866-91 (bottles of 1000) Lot #s: 9000353, exp. 11/04 and 9000681, exp.
11/04.
RECALL
EXTENDED ON 6/18/02 to the following 3 lots
NDC
#: 0046-0866-81 (bottles of 100)
Lot #: 9000477, Exp. 1/05
Distribution dates: 6/12/00-8/17/01
Quantity mfr'd: 31,310 bottles
Quantity distributed: 31,310 bottles
NDC
#: 0046-0866-91 (bottles of 1000)
Lot #: 9000682, Exp. 1/05
Distribution dates: 7/10/00 - 5/2/01
Quantity mfr'd: 2,160 bottles
Quantity distributed: 2,132 bottles
NDC
#: 0046-0866-95 (bottles of 5000)
Lot #: 9000481, Exp. 1/05
Distribution dates: 7/6/00 - 3/13/01
Quantity mfr'd: 1,308 bottles
Quantity distributed: 1,308 bottles
----------------------------------------
RECALL EXPANDED 7/16/02: The following lots
represent Batch R987005 which was manufactured January 1998.
NDC #: 0046-0866-91 (bottles of 1000)
Lot # 9980654, Exp. 1/03
Distribution dates: July 1998 - March 1999
Quantity mfr'd: 3,859 units
Quantity distributed: 3,858 units (of which 3,292 units went to wholesale
customers)
NDC #: 0046-0866-95
Lot #: 9980653, Exp. 1/03
Quantity mfr'd: 1,604 units
Quantity distributed: 1,604 units (of which 648 units went to wholesale
customers).
RECALLING FIRM/MANUFACTURER Recalling
Firm: Wyeth-Ayerst Laboratories, Richmond, VA
Manufacturer:
Ayerst Laboratories, Inc., Rouses Point, NY.
REASON Failure to meet
dissolution specifications.
VOLUME OF PRODUCT IN COMMERCE 10,285
bottles.
DISTRIBUTION Nationwide.
PRODUCT
Premarin Tablets (conjugated estrogens tablets, USP), 1.25 mg, 100 tablet
bottles, Rx only.
CODE Lot #9000481D,
Exp. 01/05 (extended recall on 7/18/2002) Lot #9980653, Exp. 01/03.
RECALLING FIRM/MANUFACTURER Recalling
Firm: National Pharmpak Services, Inc., Zanesville, OH.
Manufacturer: Ayerst Laboratories, Inc., Rouses Point, NY.
REASON Failure to meet
USP dissolution specifications by manufacturer (Wyeth).
VOLUME OF PRODUCT IN COMMERCE 9,601
bottles (lot #9000481);8,800 bottles (lot #9980653)-extension.
DISTRIBUTION Nationwide.
PRODUCT
a) Ferrex 150 Forte Capsules, Rx ONLY, 100 UNIT DOSE CAPSULES, (Each capsule
contains: Iron 150 mg, Folic Acid 1 mg,
Vitamin B12 25 mcg), NDC 51991-198-11, 10 blister packs, 10 capsules per
blister pack;
b) Vinate Ultra Prenatal Vitamin and Mineral Supplement, tablets, Rx ONLY, 100
UNIT DOSE TABLETS, NDC 51991-154-11, 10 blister packs, 10 tablets per blister
pack
CODE a) lot 021869, exp. 3/2004, NDC 51991-198-11; b) lot
014247, exp. 10/2003, NDC 51991-154-11.
RECALLING FIRM/MANUFACTURER Contract
Pharmacal Corporation, Hauppauge, NY.
REASON Mislabeled;
Exterior carton product names ( Ferrex 150/Vinate Ultra ) differs from blister
package product names (Poly-Iron 150/Ultra Natal).
VOLUME OF PRODUCT IN COMMERCE a)
52,334 blister packs total, which were packaged into unit cartons, 10 blister
packs per carton
b) 881 unit cartons.
DISTRIBUTION Nationwide.
PRODUCT
Equate Extra Strength Pain Relief PM Gelcaps (Acetaminophen 500 mg. and
Diphenhydramine HCl 25 mg)100 count bottles
CODE Lot 1MB1451.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Leiner Health Products, Carson, CA.
Manufacturer: Leiner Health Products, Wilson, NC.
REASON Contamination;
gelcaps may contain plastic/gasket material.
VOLUME OF PRODUCT IN COMMERCE 41,040
bottles.
DISTRIBUTION Nationwide.
PRODUCT
Iodine Tincture, USP Solution (sodium iodide 2.4%, iodine 2%) 1 oz. Bottle.
This product was distributed only under the Kroger brand.
CODE Lot 2611, Exp. 01/04.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Rush & Hebble Co., Inc., Edinburgh, IN
Manufacturer:
Century Pharmaceuticals, Indianapolis, IN.
REASON Labeling;
bottles labeled as Iodine Tincture contain Curechrome (benzalkonium chloride).
VOLUME OF PRODUCT IN COMMERCE 4,423
bottles.
DISTRIBUTION Nationwide.
PRODUCT
Levothroid Tablets (levothyroxine sodium tablets, USP),25-mcg.,100-tablet
bottles, Rx Only
CODE Lot #120012, Exp. 12/02.
RECALLING FIRM/MANUFACTURER Recalling
Firm: Forest Pharmaceuticals, Inc., St. Louis, MO.
Manufacturer: Forest Pharmaceuticals, Inc., Cincinnati, OH.
REASON Stability; low
potency prior to expiration.
VOLUME OF PRODUCT IN COMMERCE 14,415/100-tablet
bottles.
DISTRIBUTION Nationwide.
PRODUCT a) Air, Compressed (Medical Air,USP) UN1002, Black H
size cylinders; b) Carbon Dioxide, USP, UN1013, Black H size cylinders.
CODE Lot #QH02P135A, Exp. 05-07 #QH02P136A, Exp. 05-07
#QH02P136B, Exp. 05-07 #QH02P136C, Exp. 05-07.
RECALLING FIRM/MANUFACTURER Recalling Firm: Puritan
Medical Products, Inc., Overland Park, KS.
REASON Mislabeling: Nitrogen NF cylinders mislabeled as
Medical Air USP or Carbon Dioxide USP.
VOLUME OF PRODUCT IN COMMERCE 111 size H cylinders.
DISTRIBUTION FL.
PRODUCT a) Therevac®-SB Mini Enema (Docusate Sodium 283 mg)
Gelatin Ampules, unit doses of 5 and
30 and bottles of 10 and 30.
b)
Therevac-Plus Mini Enema w/Anesthetic, (Docusate Sodium 283 mg, Benzocaine 20 mg)
Gelatin Ampules, unit doses of 5 and 30 and bottles of 50.
CODE Therevac-SB
NDC Package Lot Number (Expiration)
52604-8317-00 1 X 5 Unit Dose K09002 (08/02), K11001 (09/02), M02001 (12/02)
52604-8317-09 6 X 5 Unit Dose K09002 (08/02), K11001 (09.02), M02001 (12/02), M06001 (04/03)
52604-8317-02 10 ct bottles K09001 (08/02), K09002 (08/02), K11001 (09/02), K12001
(11/02), K12002 (11/02), M06001 (04/03)
52604-8317-03 30 ct bottles K09001 (08/02), K09002 (08/02), K11001 (09/02), K12001
(11/02), K12002 (11/02), M01002 (11/02), M02001 (12/02), M02002 (01/03),
M06001 (04/03)
Therevac-Plus
NDC Package Lot Number/Expiration
52604-8315-00 1 X 5 Unit Dose M01001
(12/02)
52604-8315-09 6 X 5 Unit Dose K10001
(08/02), M01001 (12/02), M06002 (05/03), M10002 (09/03)
52604-8315-05 50 ct bottles K10001 (08/02),
M01001 (12/02), M01003 (11/03), M06002 (05/03).
RECALLING FIRM/MANUFACTURER Recalling Firm: King Pharmaceuticals, Inc., Bristol, TN
Manufacturer: R. P. Scherer Laboratories, St. Petersburg,
FL.
REASON Stability; product may not meet specifications
throughout the labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE 102,807.
DISTRIBUTION Nationwide.
PRODUCT GOJO Skin Lotion Medicated (Allantoin 0.7%), 5 fl oz
tubes NET 148 mL. The catalog numbers and packaging configuration are as
follows: #8140-24 (case of 24);
#8140-24-B5P00 (case of 24); #8140-06-BH200 (case of 6); #8140-12-BYR00 (case of 12)
CODE LOT NUMBERS:
134239, 138256, 147523, 151914, 152499, 153752, 160436, 169565, 170833.
RECALLING FIRM/MANUFACTURER GOJO Industries, Inc.,
Cuyahoga Falls, OH
REASON Subpotent; active ingredient Allantoin (stability).
VOLUME OF PRODUCT IN COMMERCE 12,719 cases.
DISTRIBUTION Nationwide.
PRODUCT Metformin HCl Drug Substance. Strength (Purity:) HPLC: 98.0 -102.0% Size: 50 kg Form: Crystalline Powder
Route of Administration: will eventually be used for oral dosage
form Rx, uses/application: Diabetes
Type II This is a bulk pharmaceutical drug
CODE
Lot
no. Re-evaluation date
212001MF1 Feb 2005
212101MF1 Feb 2005
212201MF1 Feb 2005.
RECALLING FIRM/MANUFACTURER ChemSource Corporation
Guayama, Puerto Rico
REASON Potential cross contamination.
VOLUME OF PRODUCT IN COMMERCE 905.2 kg, 1,157.1 kg,
1,164.0 kg.
DISTRIBUTION Nationwide.
PRODUCT Proventil® brand of (albuterol sulfate, USP)
Repetabs® brand of extended-release Tablets, 4 mg, unit dose of 100, bottles of
100 and 500, Rx only Theo-Dur® (theophylline (anhydrous)) extended-release
Tablets 200 mg, unit dose of 100, bottles of 100, 500, 1000 and 5000, Rx only
Also sold as: THEOPHYLLINE (Anhydrous) Extended-Release Tablets, 200 mg,
bottles of 100, 500 and 1000, Rx only,
Theo-Dur®
(theophylline (anhydrous)) extended-release tablet, 300 mg, unit dose of 100,
bottles of 100, 500, 1000 and 5000, Also sold as: THEOPHYLLINE (Anhydrous)
Extended-Release Tablets, 300 mg, bottles of 100, 500 and 1000, Rx only,
Theo-Dur® (theophylline (anhydrous)) extended-release tablet, 450 mg, unit dose
of 100, bottles of 100, Rx only, Also sold as: THEOPHYLLINE (Anhydrous)
Extended-Release Tablets, 450 mg, bottles of 100, Rx only Uni-Dur®
(theophylline) Extended-release Tablets, 600 mg, bottles of 100, Rx only
CODE Schering Proventil® Repetabs® brand of albuterol
sulfate, USP extended release tablets:
Lot
Number Expiration Date Lot Number Expiration
Date
0-RDR-89 November 2002 0-RDR-2014 June 2002
0-RDR-2005 April 2002 0-RDR-58 July 2002
0-RDR-2009 May 2002 1-RDR-2001 July 2002
0-RDR-2013 June 2002 1-RDR-2004 July 2002
0-RDR-72 July 2002 1-RDR-2004 November 2002
0-RDR-2004 April 2002 1-RDR-2000 July 2002
0-RDR-2006 April 2002 1-RDR-2002 July 2002
0-RDR-2008 May 2002 1-RDR-2003 July 2002
0-RDR-2010 May 2002 1-RDR-2005 November 2002
0-RDR-2011 April 2002 1-RDR-2006 July 2002
0-RDR-2012 May 2002 1-RDR-2007 November 2002
Schering
Theo-Dur® brand of theophylline, USP:
Lot
Number Expiration
Date Lot Number Expiration Date
0-KHP-439
(200mg) April 2002 0-FCY-396
(300mg) April 2002
0-KHP-440
(200mg) April 2002 0-FCY-521
(300mg) April 2002
0-KHP-515
(200mg) May 2002 0-FCY-673 (300mg) August 2002
0-KHP-581
(200mg) July 2002 0-FCY-497 (300mg) April 2002
0-KHP-395
(200mg) April 2002 0-FCY-674 (300mg) August 2002
0-KHP-524
(200mg) June 2002 1-FCY-049 (300mg) November 2002
0-KHP-675
(200mg) August 2002 0-PXG-526
(300mg) August 2002
0-KHP-462
(200mg) May 2002 0-PXG-735 (300mg) October 2002
0-KHP-736
(200mg) August 2002 0-PXG-746
(300mg) April 2002
0-FCY-379
(300mg) April 2002
Warrick
Theophylline tablets, USP:
Lot
Number Expiration
Date Lot Number Expiration Date
0-PHN-415
(200mg) April 2002 0-CGE-520 (300mg) June 2002
0-PHN-599
(200mg) August 2002 0-CGE-582
(300mg) August 2002
0-PHN-464
(200mg) May 2002 0-CGE-453 (300mg) May 2002
0-PHN-522
(200mg) May 2002 0-GNB-371 (450mg) May 2002
0-PHN-404
(200mg) April 2002 0-GNB-449 (450mg) August 2002
0-CGE-512
(300mg) May 2002 0-GNB-600 (450mg) August 2002
1-CGE-037
(300mg) August 2002
0-GNB-703 (450mg) August 2002
0-CGE-463
(300mg) May 2002
Schering
Uni-Dur® brand of theophylline, USP:
Lot
Number Expiration
Date
0-HKH-719
(600mg) June 2002.
RECALLING FIRM/MANUFACTURER Schering Corp., Kenilworth,
NJ
REASON Dissolution; failures at the sixth and eighth hour
(stability).
VOLUME OF PRODUCT IN COMMERCE Proventil Repetabs: 205,591; Theo-Dur: 191,505; Uni-Dur: 7,304, Warrick Theophylline: 616,795.
DISTRIBUTION Nationwide and Puerto Rico.
PRODUCT a) Proventil brand of (albuterol sulfate, USP)
Repetabs brand of extended-release
Tablets, 4 mg, bottles of 100, Rx only.
b)
Theo-Dur (THEOPHYLLINE(Anhydrous), Extended-Release Tablets 200 mg, bottles of
100 and 500, Rx only.
CODE a) PROVENTIL
Lot Number Exp
Date
15920 APR
02
16224 APR
02
16678 MAY
02
16745 MAY
02
010804 JUL
02
b)
THEO-DUR
Lot Number Exp
Date
16924 MAY
02
16228B MAY
02
16228A MAY
02
16411 MAY
02
RECALLING FIRM/MANUFACTURER Recalling Firm: AmeriSource Health Services Corp., Columbus,
OH
Manufacturer: Schering Corp., Kenilworth, NJ
REASON Dissolution; failures at the sixth and eighth hour
(stability) by manufacturer.
VOLUME OF PRODUCT IN COMMERCE 8,406 bottles (Proventil);
and 3,318 bottles (Theo-Dur).
DISTRIBUTION Nationwide.