NOVEMBER 2005
WEEK ENDING NOVEMBER 5
PRODUCT
Select Brand Nite Time
Cold/Flu Relief, (acetaminophen 1000mg, dextromethorphan HBr 30mg, doxylamine
succinate 12.5mg and pseudoephedrine HCl 60mg), 6 fl oz (177mL), Cherry Flavor,
over the counter, NDC #15127-880-64
CODE Lot
#L034A05A, expiry 03/07; Lot #L034A05L, expiry 03/07; Lot #L022E05K, expiry
06/07
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals LLC,
Huntsville, AL
REASON Label fails to declare correct dye colors as
FD&C blue #1 and FD&C red #40.
VOLUME OF PRODUCT IN
COMMERCE 15,896 bottles
DISTRIBUTION AR
WEEK ENDING NOVEMBER 12
PRODUCT Nitroglycerin Tablets,
USP 0.4mg (1/150gr), 100 Sublingual Tablets (4 bottles of 25 tablets each), Rx
Only, NDC 50111-989-59
CODE Lot 101105 exp. 1/07;
Lot 201105 exp. 1/07
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Pliva, Inc., East Hanover, NJ
Manufacturer: Concord Laboratories, Inc., Fairfield, NJ.
REASON
Defective container; caps on
bottles are loose which can impact product integrity.
VOLUME OF PRODUCT IN
COMMERCE 25,038 bottles
DISTRIBUTION Nationwide
PRODUCT Benazepril Hydrochloride
Tablets, 40 mg, 100-tablet bottles, ETHEX brand, Rx only, NDC 58177-344-04
CODE
Lot #62794, Exp. 11/2006
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ethex Corporation, Bridgeton,
MO,
Manufacturer: KV Pharmaceutical Co., St. Louis, MO.
REASON
Presence of Foreign Tablet;
bottle found to contain Hyoscyamine Sulfate Extended-release
Tablet.
VOLUME OF PRODUCT IN COMMERCE 13,076/100-tablet
bottles
DISTRIBUTION Nationwide
PRODUCT
a) GoodSense brand Milk
of Magnesia (magnesium hydroxide) 400 mg, Oral Liquid, Original Flavor, in
12 and 26 FL OZ bottles, Distributed by Perrigo Co., Allegan, Michigan,
NDC 0113-0396-40 ---- Product is distributed under the following brand
names: Best Yet brand, C&S Wholesale Grocers, Inc, Brattleboro, VT; Brite-Life
brand, Bergen Brunswig Drug Company, Orange, CA, NDC
24385-396-40; CVS Pharmacy brand, Woonsocket, RI; EckeRxd brand, Eckerd Drug
Co., Clearwater, FL, NDC 19458-3964-3; Equaline brand, Albertsons, Inc., Boise, ID, NDC 41163-396-35 and 41163-396-40; Equate
brand, Wal-Mart
Stores, Inc, Bentonville, AR, NDC 49035-396-35; Family Pharmacy brand,
Family
Pharmacy, Southeastern, PA, NDC 52735-508-29; Food Lion brand,
Food Lion LLC, Salisbury, NC,
NDC 55316-396-40; Good Neighbor Pharmacy,
AmerisourceBergen, Valley Forge, PA, NDC 24385-396-40; Hannaford brand,
Hannaford Bros. Co., Scarborough, ME, NDC 41268-396-40; Health Pride brand,
The Great Atlantic & Pacific Tea Co., Montvale, NJ; Healthy
Generations brand, Supervalu Inc., Eden Prairie, MN; HyVee brand, Hy-Vee,
Inc. West Des Moines, IA, NDC 42507-396-40; Kroger brand, The Kroger Co.,
Cininnati, OH, NDC 30142-396-40; Leader brand, Cardinal Health, Dublin,
OH, NDC 37205-833-40; Longs brand, Longs Drugs, Walnut Creek, CA, NDC
12333-9249-1; Medic brand, Winn-Dixie Stores, Inc., Jacksonville, FL, NDC
56039-396-40; The Medicine Shoppe brand, Medicine Shoppe International,
Inc., St. Louis, MO, NDC 49614-339-40; Meijer brand, Meijer Dist., Inc.,
Grand Rapids, MI, NDC 41250-396-35 and 41250-396-40; Publix brand,
Publix Super Markets, Inc., Lakeland, FL, NDC 56062-396-40; Roundy’s brand,
Roundy’s, Inc., Milwaukee, WI; ShopRite brand, Wakefern Food Corp, Elizabeth, NJ; Sunmark brand, McKesson, San Francisco,
CA, NDC
49348-687-39 and 49348-687-44; Swan brand, Cumberland Swan, Smyrna, TN, NDC 0869-0396-40; Top Care brand, Topco Assoc
LLC, Skokie, IL, NDC
36800-396-40 and Western Family brand,
Western Family Foods, Inc., Portland,
OR,
b) GoodSense brand Milk of Magnesia (magnesium
hydroxide), 400 mg, Oral Liquid, Mint Flavor, in 12 and 26 FL OZ bottles, Distributed by Perrigo Co.,
Allegan, Michigan, OTC. Product is
distributed under the following brand names: Best Yet brand, C&S
Wholesale Grocers, Inc, Brattleboro, VT; Brite-Life brand, Bergen Brunswig
Drug Company, Orange, CA, NDC 24385-332-40; CVS Pharmacy brand,
Woonsocket, RI; Eckerd brand, Eckerd Drug Co., Clearwater, FL, NDC
194586059-1; Equaline brand, Albertsons, Inc., Boise, ID, NDC 41163-332-35
and 41163-332-40; Family Dollar, Family Dollar Services,
Inc.,
Charlotte, NC, NDC 55319-332-40; Family Pharmacy brand, Family Pharmacy,
Southeastern, PA,
NDC 52735-520-29; Giant Eagle brand, Giant Eagle,
Inc., Pittsburgh, PA, NDC 56194-332-40; Good Neighbor Pharmacy,
AmerisourceBergen, Valley Forge, PA, NDC 24385-332-40; Hannaford brand,
Hannaford Bros. Co., Scarborough, ME, NDC 41268-332-40; Health Pride brand,
The Great Atlantic
& Pacific Tea Co., Montvale, NJ; Healthy Generations
brand, Supervalu Inc., Eden Prairie, MN, NDC 38045-332-40; HyVee brand, Hy-Vee, Inc. West Des Moines, IA,
NDC 42507-332-40; Kroger brand, The Kroger
Co., Cincinnati, OH, NDC 30142-332-40; Leader brand, Cardinal Health,
Dublin, OH, NDC 37205-834-40; Longs brand, Longs Drugs, Walnut Creek, CA, NDC
12333-9248-1; The Medicine
Shoppe brand, Medicine Shoppe International,
Inc., St. Louis, MO, NDC 49614-332-40; Meijer brand, Meijer Dist., Inc.,
Grand Rapids, MI, NDC 41250-332-35 and 41250-332-40; Publix brand, Publix
Super Markets, Inc., Lakeland, FL, NDC 56062-332-40; Roundy’s brand,
Roundy’s, Inc., Milwaukee, WI; Safeway brand, Safeway Inc., Pleasanton,
CA; NDC 21130-332-40; ShopRite brand, Wakefern Food Corp, Elizabeth, NJ;
Sunmark brand, McKesson, San Francisco, CA, NDC 49348-688-39 and
49348-688-44; Swan brand, Cumberland Swan, Smyrna, TN, NDC 0869-0332-40; Top Care brand, Topco Assoc
LLC, Skokie, IL, NDC 36800-332-40 and
Western Family brand, Western Family
Foods, Inc., Portland, OR.
c) GoodSense brand Milk of Magnesia (magnesium hydroxide),
400
mg, Oral Liquid, Cherry Flavor, in 12 and 26 ounce bottles Distributed by
Perrigo Co., Allegan, Michigan, NDC 0113-0949-40 ---- Product is distributed
under the following brand names: CVS Pharmacy brand, Woonsocket, RI;
Eckerd brand, Eckerd Drug Co., Clearwater, FL, NDC 19458-9450-1 and
19458-9450-2; Equate brand, Wal-Mart Stores, Inc, Bentonville, AR, NDC
49035-949-35; Good Neighbor Pharmacy, Amerisource Bergen, Valley Forge, PA,
NDC 24385-608-40; Healthy Generations brand, Supervalu Inc., Eden Prairie, MN, NDC 38045-949-40; HyVee brand,
Hy-Vee, Inc. West Des Moines, IA, NDC
42507-949-40; Leader brand, Cardinal Health, Dublin, OH, NDC 37205-459-40;
The Medicine Shoppe brand, Medicine Shoppe International, Inc., St.
Louis, MO, NDC 49614-338-40; Meijer brand, Meijer Dist., Inc., Grand Rapids,
MI, NDC 41250-949-35 and 41250-949-40; Publix brand, Publix Super Markets, Inc., Lakeland, FL, NDC 56062-949-40 and Sunmark brand,
McKesson, San
Francisco, CA, NDC 49348-680-39,
CODE
a) 12 oz
lots: 4LK0332, 4MD0179, 4MK0132, 4MK0286, 5AD0128, 5AD0182, 5AK0343,
5BK0081, 5CK0034, 5CK0035, 5CK0036, 5CK0236, 5CK0298, 5CK0299, 5CK0389,
5DK0077, 5DK0127, 5DK0231, 5DK0282, 5EK0377, 5FK0267, 5FK0280, 5FK0281,
5FK0393, 5GK0296, 5HK0024, 5HK0039, 5HK0107 and 5HK0375. 26 oz lots:
4MK0131, 4MK0288, 5AD0121, 5AD0126, 5AD0131, 5AK0068, 5AK0156, 5AK0348,
5BD0084, 5BK0019, 5BK0085, 5BK0322, 5BK0323, 5BK0425, 5CD0155, 5CK0073,
5CK0291, 5CK0393, 5DK0087, 5DK0116, 5ED0154, 5ED0218, 5FK0122 and
5GK0084;
b) 12 oz lots: 4LK0328, 4LK0342, 4MK0127, 4MK0128, 4MK0161,
4MK0287, 5AK0136, 5AK0137, 5AK0212, 5AK0344, 5BK0010, 5BK0011, 5BK0082,
5BK0353, 5CK0039, 5CK0078, 5CK0237, 5CK0238, 5CK0302, 5CK0390, 5DK0082,
5DK0132, 5DK0238, 5DK0239, 5ED0156R, 5EK0053, 5EK0054, 5EK0111, 5EK0335,
5EK0336, 5FK0139, 5FK0293, 5FK0346, 5GK0049, 5GK0050, 5GK0332, 5HK0034,
5HK0100 and 5HK0187. 26 oz lots: 4MK0289, 5AD0120, 5AK0110, 5AK0157,
5BK0015, 5BK0016, 5BK0017, 5BK0088, 5BK0328, 5CK0292, 5CK0394, 5DK0088,
5DK0138, 5DK0308, 5EK0119, 5EK0196, 5EK0366, 5GK0081, 5GK0082, 5GK0083,
5GK0335, 5HK0111, 5HK0195 and 5HK0292;
c) 12 oz lots: 4MD0180, 5AD0123,
5AD0213, 5BK0012, 5BK0084, 5BK0354, 5CK0074, 5CK0300, 5DK0081, 5DK0131,
5EK0365, 5FK0137, 5FK0198, 5FK0288, 5FK0290, 5FK0389, 5GK0060,
5GK0120,
5GK0297, 5HK0190 and 5HK0391. 26 oz lots: 5AD0122, 5CK0135, 5DK0140,
5DK0141, 5DK0244, 5DK0309, 5ED0120, 5EK0197, 5EK0367, 5EK0368, 5FK0135, 5FK0136, 5FK0195, 5GK0087, 5GK0336 and 5HK0110
RECALLING
FIRM/MANUFACTURER Perrigo Company, Allegan, MI,
REASON Defective Container; tamper evident seal may be
split.
VOLUME OF PRODUCT IN COMMERCE 2,114,688
bottles
DISTRIBUTION Nationwide
WEEK ENDING NOVEMBER 19
PRODUCT Olive Olea Europaea
Allergenic Extract, Contains: 0.2% Phenol, 50% v//v Glycerin, 10mL 1:20 W/V
Sterile Multiple Dose Vial, Rx only
CODE Lot #
27685, Item number G123A02
RECALLING FIRM/MANUFACTURER Greer
Laboratories, Inc., Lenoir, NC
REASON Lack of assurance of
sterility; the vials may leak due to the possibility of a faulty
seal.
VOLUME OF PRODUCT IN COMMERCE 10
vials
DISTRIBUTION AZ, CA, and FL
PRODUCT Ipratropium Bromide
Inhalation Solution, 0.02% (0.5mg/vial), 1 Foil pouch with 30 sterile 2.5 mL
Unit-Dose Vials per pouch, For oral inhalation only, Rx only, NDC 0487-9801-30
CODE
Lot Number: P5013A, Expiration Date: December
2006
RECALLING FIRM/MANUFACTURER Nephron Pharmaceuticals Corp.,
Orlando, FL
REASON Mispacked; pouches labeled to contain Ipratropium
Bromide actually contain Albuterol Sulfate Inhalation Solution
0.083%.
VOLUME OF PRODUCT IN COMMERCE 12,452 cartons of 30 vials in
a foil pouch
DISTRIBUTION Nationwide
PRODUCT Ketoconazole Shampoo,
2%, packaged in 4 fl. oz. plastic bottle, Rx only, For topical application only,
NDC 0781-7090-04
CODE Lot number:
1951
RECALLING FIRM/MANUFACTURER QLT USA, INC., Fort Collins, CO
REASON
Subpotent (6 month stability)
VOLUME OF
PRODUCT IN COMMERCE 9,145 bottles
DISTRIBUTION CO
WEEK ENDING NOVEMBER 26
Novartis Ophthalmics Recalls Seven Lots of GenTeal® Products
Novartis Ophthalmics announced today it has voluntarily recalled a total of seven lots of two products intended for use in the eye.
Novartis Ophthalmics is recalling five lots of GenTeal® Gel, a non-prescription drug product used to relieve dryness of the eye.
The five lots of GenTeal® Gel being recalled are: Lot #Z12468, 10 ml, expiration date 01/2006; Lot #Z12912, 3.5 ml, expiration date 03/2006; Lot #Z12900, 10 ml, expiration date 04/2006; Lot #Z13161, 10 ml, expiration date 05/2006; and Lot #Z13314, 3.5 ml, expiration date 06/2006. The five lots include about 142,500 tubes that were distributed nationwide from March to November 2004.
Novartis Ophthalmics is also recalling two lots of GenTeal® GelDrops. The two lots are Lot #51139, 15 ml, expiration date 07/2007; and Lot #51283, 25 ml, expiration date 07/2007. The two lots include about 12,000 dropper bottles that were distributed nationwide in October 2005.
The GenTeal® GelDrops lots are being recalled due to a lack of sterility assurance. While the risk of potential contamination is believed to be very low, contaminated product could cause infections in susceptible people, and Novartis initiated the recall as a precautionary measure. The sterility assurance issues have been corrected. Only the two distributed GenTeal® GelDrops lots are affected.
Consumers who have purchased GenTeal® Gel or GenTeal® GelDrops with any of these lot numbers should contact Novartis Ophthalmics at 1-866-393-6336.
PRODUCT Micronefrin (racemic
epinephrine) Each 100 mL contains racemic methylamino-ethanol catechol 2.25g,
For Inhalation Topical Pulmonary Chemotherapy (TPC), Mucosal Decongestant and
Bronchodilator, 15 ml and 30 ml bottles, Rx only, Made in U.S.A., NDC
12136-009-11
CODE Lot Number 297 Expiration Date
03/05, Lot Number 398 Expiration Date 12/05, Lot Number 399 Expiration Date
06/06, Lot Number 401 Expiration Date 02/07, Lot Number 297 Expiration Date
03/05, Lot Number 398 Expiration Date 12/05, Lot Number 399 Expiration Date
06/06, Lot Number 401 Expiration Date 02/07
RECALLING
FIRM/MANUFACTURER Viasys Respiratory Care, Inc., Palm Springs, CA
REASON
Lack of Assurance of Sterility; product not
manufactured sterile as required by the FDA Sterility Requirement for
Aqueous-Based Drug Products for Oral Inhalation.
VOLUME OF PRODUCT IN
COMMERCE 64,517 bottles
DISTRIBUTION Nationwide and
Internationally
PRODUCT Amino Acid Cervical
Cream, ACTIVE INGREDIENTS: Urea 8.34%, Methionine 0.83%, Inositol 0.83%, Cystine
0.35%, Net Wt. 2 3/4 Ounce Tube 77.96 Grams & Applicator, Rx only, NDC
60267-234-14
CODE Lot numbers: 40803E06/06,
40804E06/06, 41008E07/06, 50524E04/07, 50525E07/07, 50608E04/07 &
50609E04/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Hope
Medical Enterprises, Inc., Scottsdale, AZ
Manufacturer: Sheffield Laboratories, New London,
CT.
REASON Method validation
deviations for finished product testing.
VOLUME OF PRODUCT IN
COMMERCE 37,514 tubes
DISTRIBUTION Nationwide and
PR
PRODUCT Oxycodone and
Acetaminophen Capsules, USP, 5 mg/500mg Capsules, Rx only, 100 count bottles,
Qualitest® brand, NDC 0603-4997-21
CODE Lot
number: C0821203A
RECALLING FIRM/MANUFACTURER Vintage
Pharmaceuticals, Inc., Charlotte, NC
REASON Dissolution Failure (21 month
stability)
VOLUME OF PRODUCT IN COMMERCE 2,768 bottles (100
capsules/bottle)
DISTRIBUTION Nationwide
PRODUCT NeoTect Kit for the
preparation of Technetium TC-99m Depreotide Injection, Diagnostic for
intravenous use, Single use Vial, Rx only, NDC 45567-0515-3
CODE Lot number: 30121 Exp. Date: April 1,
2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: CIS-US,
Inc, Bedford, MA
Manufacturer: Rentschler Biotechnologie Gmbh & Co. KG,
Laupheim, Germany.
REASON Exceeds
Impurity specification
VOLUME OF PRODUCT IN COMMERCE 73
vials
DISTRIBUTION Nationwide