WEEK ENDING JULY 2

PRODUCT Compressed Medical Oxygen, USP, Rx product stored in D, N, and M6 size metal type cylinders
CODE Lot numbers: 990-220-01, 990-221-01, 990-222-01.
MANUFACTURER Homecare Concepts, Inc., Farmingdale, New York.
DISTRIBUTION New York.
QUANTITY 65 cylinders were distributed.
REASON Incomplete testing for strength and identity.

PRODUCT Cephradine Capsules USP, 250 mg in bottles of 100, Rx indicated in the treatment of respiratory tract infection, otitis media, skin and skin-structure infections, and urinary tract infections. NDC #0093-3153-01.
CODE Lot #56214 EXP 9/99.
MANUFACTURER Teva Pharmaceuticals, USA, Inc., Sellersville, Pennsylvania.
DISTRIBUTION Nationwide.
QUANTITY Approximately 10,852 bottles were distributed; firm estimated that 2,700 bottles remained on market at time of recall initiation.
REASONSubpotency (stability).

PRODUCT Rx controlled-substance cough syrups:
a) ENDOTUSS HD(tm) Syrup, (Hydrocodone Bitartrate 1.67 mg, Phenylephrine Hydrochloride 5 mg, Chlorpheniramine Maleate 2 mg), in one pint (473 mL) bottles
b) POLYTINE D(tm) Syrup, (Phenylpropanolamine Hydrochloride 12.5 mg, Phenyltoloxamine Citrate 4 mg, Pyrilamine Maleate 4 mg, Pheniramine Maleate 4 mg, Alcohol 4%), in one pint (473mL) bottles
c) POLYTINE CS (tm) Syrup, (Codeine Phosphate 10 mg, Phenylpropanolamine Hydrochloride 12.5 mg, Brompheniramine Maleate 2 mg), in one pint (473 mL) bottles
d) CO-TUSSIN(tm) Syrup, (Hydrocodone Bitartrate 5 mg, Guaifenesin 100 mg) in one pint (473 mL ) bottles, all lot numbers. Recall #D-269/271-9 and D-273-9.
CODE (a) NDC 58634-0004-1 (EndoTuss HD)
Lot Numbers/Exp. Dates:
AA146, 09/2000
AA152, 09/2000
AA159, 11/2000
AA164R, 12/2000
AA170, 2/2001
AA173, 3/2001
b) NDC 58634-0010-1 (Polytine D)
Lot Numbers/Exp. Date:
AA153, 9/2000
AA156, 10/2000
AA163, 11/2000
AA169, 3/2001
c) NDC 58634-0009-1 (Polytine CS)
Lot Numbers/Exp. Date:
AA154, 10/2000
AA160, 11/2000
AA166, 1/2001
AA177, 3/2001
d) NDC 58634-0032-1 (CoTussin)
Lot Numbers/Exp.Date:
AA161, 11/2000
AA162, 12/2000
AA165, 12/2000
AA168, 2/2001
AA172, 3/2001
AA174, 3/2001.
MANUFACTURER Signature Pharmaceuticals, Inc., Gloversville, New York.
DISTRIBUTION Nationwide.
QUANTITY
a) EndoTuss HD: 16,165/one pint (473 ml) bottles
b) Polytine D: 9,103/one pint (473 ml) bottles
c) Polytine CS: 5,293/one pint (473 ml) bottles
d) CoTussin: 13,410/one pint (473 ml) bottles were distributed.
REASON Lack of data to support labeled expiration date.

PRODUCT Supac Analgesic Tablets (Acetaminophen 160 mg, Aspirin 230 mg, Caffeine 33 mg),
in 100 and 1,000 tablet bottles, OTC analgesic. NDC Numbers: 0178 0100 01 and 0178 0100 10.
CODE
Lot Numbers Expiration Date
6A12 January 1999
6G53 July 1999
7F14 June 2000
7K72 October 2000
8D63 October 1999.
MANUFACTURER Mission Pharmacal Company (MPC), San Antonio, Texas.
DISTRIBUTION Nationwide.
QUANTITY 7,703 100-tablet bottles and 784 1,000-tablet bottles were distributed.
REASON Free Salicylic Acid values exceed USP limit and/or content uniformity failures for caffeine.

PRODUCT Tilade Inhaler (Nedocromil Sodium Inhalation Aerosol) 1.75 mg per actuation, 8.5 g (52 metered inhalations) professional samples, an inhaled anti-inflammatory agent for the preventive management of mild to moderate asthma in adult and pediatric patients 6 years of age and older. NDC 0585-0685-98.
CODE Lot #A70732 EXP 8/99.
MANUFACTURER Fisons PLC Pharmaceutical Division, United Kingdom.
RECALLED BY Rhone Poulenc Rorer, Collegeville, Pennsylvania
DISTRIBUTION Missouri and Arkansas.
QUANTITY 16 inhalers were distributed; firm estimates none remain on the market.
REASON Failure to meet dose uniformity requirements.
 

WEEK ENDING JULY 9

PRODUCT Levothroid (levothyroxine sodium tablets USP), 50 mcg, packed in 100 tablet bottles, Rx indicated as replacement therapy for diminished thyroid function resulting in hypothyroidism. NDC #00456-0321-01
CODE Lot #10436.
MANUFACTURER Forest Pharmaceuticals, St. Louis, Missouri.
RECALLED BY AmeriSource Health Services Corporation, doing business as American Health Packaging, Columbus, Ohio
DISTRIBUTION Ohio, Minnesota, Kentucky, Indiana, Florida, New Jersey, Alabama, Maine, Virginia, Georgia, Oregon, Connecticut California, North Carolina.
QUANTITY 500 bottles were distributed.
REASON Subpotency (stability).

PRODUCT Amicar Syrup 25% (Aminocaproic Acid), each teaspoon (5mL) contains 1.25 g Aminocaproic Acid, in 16 fluid ounce bottles, Rx useful in enhancing hemostasis when fibrinolysis contributes to bleeding. NDC # 58406-611-90.
CODE Lot numbers: 452-657 EXP 1/2001, 452-658 EXP 1/2001, 452-659 EXP 1/2001, 452-660 EXP 2/2001.
MANUFACTURER Lederle Laboratories, Pearl River, New York.
RECALLED BY Immunex Corporation, Seattle, Washington
DISTRIBUTION Nationwide.
QUANTITY 2,888 bottles of lot 452-657, 2,871 bottles of lot 452-658, 1,514 bottles of lot 452-659 7 bottles of lot 452-660 were distributed.
REASON USP antimicrobial effectiveness test failure (stability).

PRODUCT Vivactil 5 mg Tablets (Protiptyline HCl), in bottles of 100, Rx indicated for the treatment of symptoms of mental depression, particularly for withdrawn and anergic patients. NDC #0006-0026- 68.
CODE LOT NOS. A7302 EXP 7/99, B6484 EXP 7/99, B5808 EXP 1/00, B8983 EXP 1/00, B8983SA EXP 1/00, D5744 EXP 1/01,D5039 EXP 4/01, and E6209 EXP 10/01.
MANUFACTURER Merck & Company, Inc., West Point, Pennsylvania.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 1,000 units remained at wholesale level at time of recall initiation.
REASON Subpotency (stability).
 

WEEK ENDING JULY 16

PRODUCT Medicap Pharmacy Peri-Colace Stool Softener With Laxative containing 100 mg of Docusate Sodium and 30 mg of Casanthranol per softgel, 100 softgels per bottle. NDC number is 56050-254-52.
CODE Lot #4985A EXP 7/00.
MANUFACTURER Time-Cap Labs., Inc., Farmingdale, New York (Manufacturer of the bulk aspirin which was repacked and then mislabeled as Peri-Colace).
RECALLED BY Apothecary Products, Inc., Burnsville, Minnesota (repacker)
DISTRIBUTION Undetermined.
QUANTITY 12 bottles in 2 boxes of 6 bottles each were distributed.
REASON Mislabeling - Bottles actually contain 325 mg aspirin tablets.

PRODUCT Calcionate Syrup, in 16 fluid ounce (pint) bottles, OTC calcium supplement
CODE Lot #802921. EXP 7/00.
MANUFACTURER Hi-Tech Pharmacal Company, Inc., Amityville, New York.
DISTRIBUTION Georgia.
QUANTITY 3,564 units were distributed.
REASON Presence of white precipitate and cloudiness; calcium is precipitating out of formulation.
 

WEEK ENDING JULY 23

PRODUCT Trihexyphenidyl Hydrochloride Tablets, 5 mg, in 100 tablet blister strips of 10 tablets, Rx oral antispasmodic tablet used as an adjunct in the treatment of all forms of parkinsonism. NDC 51079-124-20.
CODE Lot #8V938.
MANUFACTURER Lederle Pharmaceutical, Division of American Cyanamid, Pearl River, New York.
RECALLED BY UDL Laboratories, Inc., Rockford, Illinois (repacker)
DISTRIBUTION Nationwide.
QUANTITY 3,624 unit cartons were distributed; firm estimated that 25 percent of the product remained on market at time of recall initiation.
REASON Mislabeling - Some blister strips are held in shelf unit cartons (100's) labeled as Allopurinol Tablets, 300 mg. The blister strips are correctly labeled.
 

WEEK ENDING JULY 30

PRODUCT Rowasa Rectal Suppositories (Mesalamine, 500 mg), in cartons of 12, 24, and physician sample of 2's, Rx indicated for the treatment of active ulcerative proctitis.
CODE All lot numbers remaining within expiration date.
MANUFACTURER G&W Laboratories, Plainfield, New Jersey (contract manufacturer).
RECALLED BY Solvay Pharmaceuticals, Marietta, Georgia
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY 307,137 cartons of 12; 254,946 cartons of 24;and 100,281 pyhysician samples were distributed.
REASON Dissolution failure and/or lack of assurance of stability through labeled expiry date.

PRODUCT M.V.I. Pediatric, multi-vitamins for infusion, in single dose 10 Ml vials. NDC #0186-1839-31.
CODE Lot #813011 EXP 7/99.
MANUFACTURER Catalytica Pharmaceuticals, Inc., Greenville, North Carolina.
RECALLED BY AstraZeneca LP, Westborough, Massachusetts
DISTRIBUTION Nationwide.
QUANTITY 8,392 were manufactured; firm estimated that 5-10 percent remained on market at time of recall initiation.
REASON Folic acid and Vitamin B12 levels below potency specification prior to expiration.

PRODUCT Nystatin Oral Suspension, USP, 100,000 units per Ml, Fruit Flavored, Rx in 2 ounce and 1 pint units, used for the treatment of candidiasis of the oral cavity, under the Morton Grove, NDC #60432-537-16 & 60432-537-60, and Schein labels, NDC #0364-2075-58;
b) Generlac Solution (Lactulose Solution, USP), 10g/15Ml, for oral or rectal administration, Rx in one pint (473 Ml) containers, an Rx oral colonic acidifier for the prevention and treatment of portal-systemic encephalopathy, under the Morton Grove label. NDC #60432-038-16.
CODE Lot numbers: a) 21533, 21720, 21776, 22118, 22325, 21616 and 22279; b) 21767.
MANUFACTURER a) Morton Grove Pharmaceuticals, Inc., Morton Grove, Illinois; b) Morinaga Milk Industry Company, Ltd., Tokyo, Japan.
DISTRIBUTION Nationwide.
QUANTITY a) 26,136 pints and 50,263 2-fluid ounce bottles were distributed; b) 21,105 pints were distributed; firm estimated that 10 percent of product remained on market at time of recall initiation.
REASON Microbial contamination (acinetobacter baumanii).

PRODUCT Prednisolone Acetate Ophthalmic Suspension, USP, Sterile, 1%, in 10Ml units, under the Alcon (NDC #0998-0637-05) and Falcon (NDC #61314-637-10) labels.
CODE Lot numbers: 57984P and 58005P.
MANUFACTURER Alcon (Puerto Rico), Inc., Humaco, Puerto Rico.
RECALLED BY Alcon Laboratories, Inc., Fort Worth, Texas
DISTRIBUTION Nationwide.
QUANTITY 64,175 units were distributed.
REASON Loose clumping (agglomeration) of active ingredient.

PRODUCT Atenolol Tablets USP packaged in: a) 25 mg; b) 50 mg; c) 100 mg. All three strengths were packaged and distributed in bottles of 100's and 1000's, Rx used in the management of hypertension. NDC Numbers:
25 mg: Bottle of 100, NDC 0005-3218- 43 Bottle of 1000 NDC 0005-3218-34
50 mg: Bottle of 100 NDC 0005-3219-43 Bottle of 1000 NDC 0005-3219-34
100 mg: Bottle of 100 NDC 0005-3220-43 Bottle of 1000 NDC 0005-3220-34.
CODE a) 25 mg, Bottles of 100: D454-909 (EXP 03/01), D454-910 (EXP 03/01), D457-101 (EXP 06/01)
D457-102 (EXP 06/01), D457-103 (EXP 06/01), D459-493 (EXP 09/01), D459-386 (EXP 09/01)
D459-390 (EXP 09/01)
25 mg, Bottles of 1000: D457-100 (EXP 06/01), D457-104 (EXP 06/01), D459-385 (EXP 09/01)
D459-387 (EXP 09/01), D459-389 (EXP 09/01)
c) 50 mg, Bottles of 100: D449-230 (EXP 07/00), D453-456 (EXP 02/01), D453-457 (EXP 02/01)
D457-107 (EXP 06/01), D459-404 (EXP 09/01)
b) 50 mg, Bottles of 1000: D449-040 (EXP 07/00), D449-041 (EXP 07/00), D449-042 (EXP 07/00)
D449-228 (EXP 07/00), D449-229 (EXP 07/00), D449-231 (EXP 07/00), D451-212 (EXP 10/00)
D451-213 (EXP 10/00), D451-318 (EXP 10/00), D451-319 (EXP 10/00), D453-453 (EXP 02/01)
D453-454 (EXP 02/01), D453-455 (EXP 02/01), D457-105 (EXP 06/01), D457-106 (EXP 06/01)
D457-108 (EXP 06/01), D458-707 (EXP 06/01), D457-110 (EXP 06/01), D457-111 (EXP 07/01)
D457-112 (EXP 07/01), D457-113 (EXP 07/01), D457-114 (EXP 07/01), D459-398 (EXP 09/01)
D459-400 (EXP 09/01), D459-402 (EXP 09/01), D460-390 (EXP 10/01), D460-391 (EXP 10/01)
D460-392 (EXP 10/01)
c) 100 mg, Bottles of 100: D459-520 (EXP 09/01), D459-521 (EXP 09/01), D461-521 (EXP 01/02)
100 mg, Bottles of 1000: D449-233 (EXP 07/00), D457-115 (EXP 07/01), D457-116 (EXP 07/01)
D457-117 (EXP 07/01)
MANUFACTURER Wyeth-Ayerst Pharmaceuticals, Inc., Pearl River, New York.
RECALLED BY Wyeth-Ayerst Laboratories, Richmond, Virginia
DISTRIBUTION Nationwide, Puerto Rico, Virgin Islands, Taiwan.
QUANTITY 583,586 bottles were distributed August 1997 to May 1999 as follows:
a) 25 mg: 347,824 bottles total: 330,463 bottles of 100 and 17,361 bottles of 1000
b) 50 mg: 196,773 bottles total: 126,098 bottles of 100 and 70,675 bottles of 1000
c) 100 mg: 38,989 bottles total: 33,919 bottles of 100 and 5,070 bottles of 1000.
REASON Content uniformity failure.