WEEK ENDING JANUARY 7

PRODUCT Acetaminophen Tablets Extra Strength, 500 mg, bottles of 100, OTC pain reliever under the following brand names:
a) ARBOR brand NON-ASPIRIN PAIN RELIEF EXTRA STRENGTH. Distributed by Arbor Drugs, Inc., Troy, Michigan. NDC 50165-405-78.
b) Chateau brand EXTRA STRENGTH Non-Aspirin Tablets, Distributed by Preferred Products, Inc., Eden Prairie, MN. [label bears no NDC#].
c) Drug Guild brand EXTRA STRENGTH NON-ASPIRIN PAIN RELIEF, Distributed by Drug Guild Distributors, Inc., Secaucus, New Jersey. [label bears no NDC#].
d) Equate brand extra strength NON-ASPIRIN PAIN & FEVER RELIEF. Manufactured by Perrigo Co., Allegan, MI. [Label bears no NDC#].
e) FOOD LION brand Extra Strength PAIN RELIEVER, Distributed by Food Lion, Inc., Salisbury, NC 28144. [Label bears no NDC#].
f) GOOD SENSE brand EXTRA STRENGTH NON-ASPIRIN PAIN RELIEVER, Perrigo, Allegan, MI. [Label bears no NDC#]
g) Kroger brand EXTRA STRENGTH Pain Reliever Acetaminophen, 500 mg, Distributed by The Kroger Co., Cincinnati, Ohio. [label bears no NDC#].
h) Marquee brand EXTRA STRENGTH Non-Aspirin Pain Reliever-Fever Reducer Acetaminophen, 500 mg, Distributed by Fleming Companies, Inc., Oklahoma City, OK 73216. NDC 11205-405-78.
i) NEX brand EXTRA STRENGTH Pain Reliever Acetaminophen, 500 mg, Distributed by Nexcom, Virginia Beach, Virginia. [label bears no NDC#].
j) Shurfine brand EXTRA STRENGTH Non-Aspirin, 500 mg Distributed by Shurfine International, Inc., Northlake, IL 60164-1889. [label bears no NDC#].
k) spartan brand extra strength pain reliever without aspirin Acetaminophen - Strong Pain & Fever Relief, 500 mg, Distributed by Spartan Stores, Inc., Grand Rapids, Michigan. NDC 11213-405-78.
l) STOP & SHOP brand PAIN RELIEF, 500 mg, Distributed by Stop & Shop Supermarket Co., Boston, Massachusetts. [label bears no NDC#].
m) TOP CARE brand EXTRA STRENGTH ASPIRIN FREE Pain Relief, 500 mg., Distributed by Topco Associates, Inc., Skokie, Illinois NDC 36800-405-78.
CODE Lot #8EC037.
MANUFACTURER Perrigo Company, Allegan, Michigan.
DISTRIBUTION Nationwide.
QUANTITY 44,736 bottles of 100 were distributed.
REASON Tablet discoloration due to mold (penicillium species).

PRODUCT Ammonia Inhalants (Alcohol 35%, Ammonia 15%), in 0.33 mL ampoule, 12 units per box, used to prevent or treat fainting via nasal inhalation. NDC #0839-8080-03.
CODE Lot #3398C EXP 3/2003.
MANUFACTURER James Alexander Corporation, Blairstown, New Jersey (contract manufacturer/packager).
RECALLED BY Moore Medical Corporation, New Britain, Connecticut,
DISTRIBUTION Undetermined.
QUANTITY 282 packers (40,608 inhalants) were distributed.
REASON Mislabeling - Holding carton incorrectly labeled as amyl nitrite.

PRODUCT Hydromorphone HCL, USP, Rx bulk active ingredient.
CODE Lot Numbers: B1016-980201, B1016-980701, B1016-980802.
MANUFACTURER Johnson Matthey, West Deptford, New Jersey.
DISTRIBUTION Minnesota, Colorado, Texas, Kansas.
QUANTITY Firm estimates none remains on the market.
REASON Black specks in product (graphite).

PRODUCT SeptisolÆ Solution, Handwash, Triclosan 0.25%, in 8-ounce, 1-quart, and 1-gallon plastic containers, OTC broad spectrum, fast acting handwash to decrease the level of transient microorganisms on the skin before contact with patients under medical care or treatment.
CODE
217034 EXP 12/31/1999
217309, EXP 1/31/2000
218107, EXP 3/31/2000
218134, EXP 3/31/2000
218748, EXP 6/30/2000
219650, EXP 9/31/2000 and EXP 10/31/2000
220065, EXP 11/30/2000.
MANUFACTURER Steris Corporation, St. Louis, Missouri.
RECALLED BY Steris Corporation, Mentor, Ohio
DISTRIBUTION Nationwide.
QUANTITY 481 (48 8-fluid ounce bottle) cases, 2,426 (12 1-quart bottle) cases, and 12,106 (4 1-galllon bottle) cases were distributed.
REASON Subpotency (9-month stability).

PRODUCT Klaron (r) Lotion (Sodium sulfacetamide), 10%, in 2-ounce and 8-mL units, Rx indicated for the topical treatment of acne vulgaris in individuals who have sensitive skin.
CODE Lot 85292 EXP 1/00 and Lot 84899 EXP 9/99. 2 ounce bottles, NDC 0066-7500-02 8 ml bottles, NDC 0066-7500-11 -physician samples.
MANUFACTURER Rhone-Poulenc Rorer Pharmaceuticals, Collegeville, Pennsylvania.
DISTRIBUTION Nationwide and the Caribbean.
QUANTITY Firm estimated that there were no trade units left on the market and approximately 1000 (12 x 8 ml) units remained in the field at time of recall initiation.
REASON Subpotency at stability 21 months.

PRODUCT NovolinÆ 70/30 PenFillÆ (70% NPH, Human Insulin Isophane suspension 30% Regular, Human Insulin Injection-recombinant DNA origin), 1.5 mL cartridges, 100 units/mL (U-100) in cartons of 5, Rx, intended usage is for individuals diagnosed with diabetes requiring injections of insulin as prescribed by their physician. NDC #0169-1837-17.
CODE Lot Numbers: 9G14006 EXP 7/01 and 9J14015 EXP 9/01.
MANUFACTURER Novo Nordisk A/S, Bagsvaerd, Denmark.
RECALLED BY Novo Nordisk Pharmaceuticals, Inc., Princeton, New Jersey
DISTRIBUTION Nationwide.
QUANTITY Approximately 11,816 cartons (5 cartridges/carton) were distributed.
REASON Mislabeling - Label lacks listing of phenol 0.068% as ingredient/preservative.

PRODUCT Acetaminophen Caplets Extra Strength, 500 mg, bottles of 100, OTC pain reliever.
CODE Lot #9JE0735 EXP 9/02.
MANUFACTURER Perrigo Company, Allegan, Michigan.
DISTRIBUTION Nationwide.
QUANTITY 71,100 bottles of 100 were distributed.
REASON Mislabeling - Some bottles were incorrectly labeled as containing ibuprofen (200 mg).

PRODUCT Ibuprofen Tablets, 200 mg, bottles of 100, OTC pain reliever.
CODE Lot #9GE0151.
MANUFACTURER Perrigo Company, Allegan, Michigan.
DISTRIBUTION Nationwide.
QUANTITY 4,200 bottles were distributed.
REASON Superpotency - Some tablets may be oversized.

PRODUCT Muscle MagicÆ Topical Analgesic CrËme (Methyl Salicylate 10%, Menthol 1%), in 16-ounce and 8-pound units, OTC intended for effective temporary relief of minor pain and soreness of muscles and joints.
CODE Lot Numbers: 7H39 and 8E53.
NDC #0178-1105-16 - 16 ounces
NDC #0178-1105-08 - 8 ounces.
MANUFACTURER Mission Pharmacal Company (MPC), San Antonio, Texas.
DISTRIBUTION Nevada, New York, Pennsylvania, Texas.
QUANTITY 1,532 16-ounce and 408 8-pound containers were distributed.
REASON Stability - Non-uniformity in potency results to support labeled expiration date.
 

WEEK ENDING JANUARY 14

PRODUCT A) Various pharmaceutical ingredients, repacked on the same day after penicillin products were repackaged in the same facility using common packing and labeling equipment:
1) Brompheniramine powder, 100 g units, antihistamine
2) Castor Oil, USP, 3840 mL and 500 mL, laxative
3) Choline Chloride FCC, 500 g and 1 kg, supplement
4) Chromium Picolinate (Picolinic Acid, Chromium Salt Powder), 122.5 mg Cr/g, 5 g, supplement
5) Ergononvine Maleate, USP, 5g, 200 g, & 350 g, uterine stimulan/migraine treatment
6) Estriol, USP, micronized, 1 g, 5 g, 25 g, & 100 g, hormone replacement
7) Fluoxetine HCL, 7 g, 6 g, 10 g, & 20 g, antidepressant
8) Glycerol Formal liquid, 3840 mL, solvent
9) Haloperiodol, USP, 1 g and 5 g, antipsychotic
10) Liver Extract, 100 g, supplement
11) Naltrexone Hydrochloride 25 g, opiate antagoist
12) Phentolamine Mesylate, USP, 500 mg, 1 g, alpha-blocker
13) Progesterone USP, Micronized, 89 g, 100 g, 1 kg, 5kg, and 500 kg, hormone replacement
14) Riboflavin USP (Vitamin B12), 25 g and 100 g, supplement
15) Tetracaine, USP, 3.75 g, 5 g, and 25 g, topical anesthetic
16) Trimethoprim, USP (non-micronized), 100 g, 500 g, and 1 kg, antibiotic. Recall #D-162/177-0.
B) Active and inactive pharmaceutical ingredients repacked on the same day after cephalosporin products were repackaged, in the same facility and using common packing and labeling equipment.
1) Cyclosporin A, USP, Powder, 500 mg and 1 g, antibiotic
2) Dermabase cream, 454 g, cream
3) Dihydroergotamine Mesylate, USP, powder, 5 g, migraine treatment
4) Hydroxocobalamin, USP, (Vitamin B-12), 250 mg and 1 g, supplement
5) Ketoprofen, USP, powder, 100 g, anti-inflammatory
6) Progesterone, USP, micronized, powder, 25 g, hormone replacement
7) Reserpine, USP, powder, .91 g, 1 g, 5 g, hypertension.
CODE
(A) Lot Numbers:
1) 98291211; 2) 97280806 and 97280807 3) 97280808 and 97280809; 4) 98250610 and MB0295 5) 99230705, 99230709, 99230710; 6) 99200813, 99200815, 99200816, 99200817 7) 97120808, 97120808, 97120809; 8) 98140511 9) 98250611, 98250612; 10) 98250607; 11) 98060306
12) 99230703 99230704 S9230704; 13) 99072310, 99072311, 99072312, 99230713, 99200814, S9200814 14) 98250608 and 98250609; 15) 98250604, 98250605, 98250606 16) 98060307, 98060308, 98060309, 99070104.
(B) Lot Numbers:
1) 98121005 and 98121006 2) 8G6104 3) 98231111 4) 98121003 and 98121004 5) 98231110 6) 98231109 7)98121007, 98121008, 98121009.
MANUFACTURER Oribi, Inc., doing business as Meridian Chemical and Equipment, Amarillo, Texas.
DISTRIBUTION Nationwide.
QUANTITY Approximately 340 containers were distributed.
REASON A) Products were packaged on the same equipment as penicillin products.
B) Products were packaged on the same equipment as cephalosporin products.

PRODUCT a) Kefurox(r), Cefuroxime for Injection, USP, 1.5 g, Rx broad spectrum antibiotic. NDC #0002-7272-10
b) Mandol(r), Cefamandole Nafate for Injection, USP, 1 g, Rx broad spectrum antibiotic. NDC #0002-7061-25.
CODE Lot Numbers: a) S7750Y1; b) S2556Y1.
MANUFACTURER Eli Lilly Italia, Sesto, Italy.
RECALLED BY Eli Lilly and Company, Indianapolis, Indiana
DISTRIBUTION Nationwide and Santo Domingo.
QUANTITY a) 28,330 vials; b) 45,625 vials were distributed.
REASON Lack of assurance of sterility.

PRODUCT Compressed Medical Oxygen, USP, Rx in size D, E and M6 cylinders.
CODE Lots
12109901 11229902
04099902 08259901
02229901 08209901
08209903 10069901
08259901 11089904
10069901 11229903
08209902 01199901
10069902 05319903
11089902 11229904
12089902 12089901.
MANUFACTURER Gretna Drug Company, Inc., Gretna, Virginia.
DISTRIBUTION Virginia.
QUANTITY 27 cylinders were distributed and subsequently retrieved.
REASON Current good manufacturing practice deviations, including but not limited failure to perform and/or document calibration of the oxygen analyzer.

PRODUCT Vanceril(r) Double Strength Inhalation Aerosol (Beclomethasone Dipropionate), 84 mcg, in 5.4 g inhalers, 3 per holding carton, Rx indicated for the maintenance treatment of asthma. NDC: 0085-1112-03.
CODE LOT Numbers: 9-DMT-157, 9-DMT-158, 9-DMT-160, 9-DMT-161, and 9-DMT-163. EXP for all lots: 7/2000.
MANUFACTURER Schering Laboratories, Inc., Kenilworth, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY 82,029 units were distributed; firm estimates none remain on the market.
REASON Some units may not contain any active drug substance.

PRODUCT Potassium Chloride (Klor-Con) Packets, 20mEq/4-ounce packets, Rx. NDC #0245-0035-01.
CODE Lot Numbers: 18264 1 EXP 2/01 and 18308 1 EXP 4/01.
MANUFACTURER Med-Pro, Inc., Lexington, Nebraska (repacker).
DISTRIBUTION Colorado.
QUANTITY 24 100-packet boxes of lot 18264 and 26 100-packet boxes of lot 18308 were distributed.
REASON Mislabeling - Exterior plastic holding packet incorrectly labels the product as 20 mEq granules not 10 mEq tablets.

PRODUCT Nitrous Oxide, USP, 99%, Compressed, in cylinders "K", "T", "E", "D", "M" and "Q"; b) Nitrous Oxide, USP, 99%, liquid, 20 lb. "H" cryogenic vessels.
CODE All lot numbers.
MANUFACTURER Praxair Distribution, Inc., Seattle, Washington.
DISTRIBUTION Washington state, Oregon, Alaska, Florida, Colorado, Utah, Canada.
QUANTITY Approximately 948,000 pounds were distributed over a 6-month period; firm estimated that 40,000 pounds of the distributed product remained on market at time of recall initiation.
REASONCurrent good manufacturing practice deviations: Failure to correctly perform and document assay (potency tests).
 

WEEK ENDING JANUARY 21

PRODUCT Dihydroergotamine Mesylate Powder, Rx bulk active ingredient, in 250 mg, 1 g and 5 g containers.
CODE Lot Numbers: NL0465, OC0650, OG0622. EXP 05/31/02 for all lots.
MANUFACTURER Spectrum Laboratory Products, Inc., Gardena, California (repacker/responsible firm).
DISTRIBUTION California, Colorado, Georgia, North Carolina, Oregon, Rhode Island, Texas, Utah.
QUANTITY 20 grams were distributed.
REASON Possible cross contamination with cefadroxil.

PRODUCT Naproxen Tablets, USP, 500 mg, in 100, 500 and 1,000 tablet bottles, Rx.
CODE
NDC# (TABS) Lot# EXP
0781-1165-10 (1000's) 106583 04/02
0781-1165-05 ( 500's) 106584 04/02
0781-1165-01 ( 100's) 106585 05/02
0781-1165-10 (1000's) 106585 05/02
0781-1165-05 ( 500's) 105921 04/02
0781-1165-05 ( 500's) 106119 04/02.
MANUFACTURER Geneva Pharmaceuticals, Inc., Broomfield, Colorado.
DISTRIBUTION Nationwide.
QUANTITY
Lot# Distributed
106583 (1000's) 1,719,000
106584 ( 500's) 1,569,500
106585 ( 100's) 489,600
106585 (1000'S) 971,000
105921 (500'S) 1,743,500
106119 (500'S) 1,716,500.
REASON Metal wire/particle contamination.

Naproxen Tablets, USP, 500 mg, in 100, 500, and 1,000 tablet bottles, Rx (Geneva Pharmaceuticals, Inc.,
Broomfield, Colorado), has been extended to include the following:
NDC# LOT# EXP Distributed (tablets)
0781-1165-10 (1000's) 105841 04/02 1,724,000
0781-1165-10 (1000's) 106208 04/02 1,731,000
0781-1165-10 (1000's) 106209 04/02 1,724,000
0781-1165-01 (100's) 106234 04/02 1,587,900
0781-1165-13 (UD) 106234 04/01 96,300
0781-1165-05 (500's) 106235 04/02 1,709,500
0781-1165-13 (UD) 106442 04/01 96,100
0781-1165-10 (1000's) 106442 04/02 1,627,000
0781-1165-10 (1000's) 106512 04/02 1,722,000
0781-1165-05 (500's) 106753 05/02 1,754,500
0781-1165-05 (500's) 106754 05/02 1,749,000
0781-1165-10 (1000's) 106755 05/02 1,722,000
0781-1165-05 (500's) 106980 05/02 1,704,000
0781-1165-01 (100's) 107145 05/02 1,728,100
0781-1165-10 (1000's) 107146 05/02 1,671,000
0781-1165-10 (1000's) 107245 05/02 1,638,000
0781-1165-05 (500's) 107246 05/02 1,668,000
0781-1165-01 (100's) 107354 05/02 422,000
0781-1165-10 (1000's) 107355 05/02 1,668,000.

PRODUCT Oxytocin Injection, USP (synthetic), 10 USP units/mL, 1 mL, (3cc plastic vial), Rx indicated for the initiation or improvement of uterine contractions to induce labor. NDC #N0469-002-061.
CODE Lot #392002 EXP 04/00.
MANUFACTURER American Pharmaceutical Partners, Inc., Grand Island, New York.
DISTRIBUTION Nationwide.
QUANTITY 294,350 units were distributed; firm estimates none remains on the market.
REASON Subpotency.

PRODUCT Radic Electrolyte Formula, liquid, in 8-ounce clear plastic bottles, OTC dietary supplement to help the body heal itself naturally.
CODE Uncoded. All 8-ounce product.
MANUFACTURER Medical Research Products, also known as Consolidated Marketing Ltd., Miami, Florida.
RECALLED BY Hope For Life Foundation of Southern California, Mission Viejo, California
DISTRIBUTION California and Nevada.
QUANTITY Approximately 20 bottles were distributed; firm estimates none remains on the market.
REASON Product contains catechol (carcinogen).

PRODUCT Diltiazem Hydrochloride Extended Release Capsules, USP, 120 mg,in 100-capsule bottles, Rx indicated for angina pectoris due to coronary artery spasms.
CODE Lot #11829 EXP 2/01.
MANUFACTURER Teva Pharmaceuticals USA, Sellersville, Pennsylvania.
DISTRIBUTION Nationwide.
QUANTITY 9,597 bottles were distributed.
REASON Dissolution failure at 3 months stability.

PRODUCT Quinidine Gluconate Extended Release Tablets, USP, 324 mg, in 100, 250, and 500-tablet bottles, Rx used as an antimalaria and antiarrhythmic.
CODE NDC-0364-0604-01 bottles of 100's; C8D0669 (04/00), C8D0670 (04/00), C8E1066 (06/00), C8E1068 (06/00), C8F1173 (07/00), C8F1174 (07/00), C8F1234 (08/00) NDC-0364-0604-04 bottles of 250's; C8B0265 (04/00), C8B0266 (04/00), C8D0671 (04/00), C8D0672 (04/00), C8D0673 (04/00), C8E1070 (06/00), C8E1071 (06/00), C8F1170 (07/00), C8F1171 (07/00), C8F1235 (08/00) NDC-0364-0604-05 bottles of 500's; C8B0263 (04/00), C8B0264 (04/00), C8E1067 (06/00), C8E1069, C8F1172.
MANUFACTURER Danbury Pharmacal, Inc., Carmel, New York.
RECALLED BY Schein Pharmaeuticals, Inc., Brewster, New York
DISTRIBUTION Nationwide.
QUANTITY 15,682 bottles of 100's; 12,530 bottles of 250's 1,838 bottles of 500's were distributed.
REASON Product may not meet dissolution specification over labeled expiration period.

PRODUCT Cyclosporine, USP, Non-Sterile, powder, bulk active ingredient, Rx immunosuppressant agent used for the prophylazis of organ rejection in kidney, liver and heart allogenic transplants, in various sizes.
CODE Lot Numbers: 49-365-IL-00 and 51-379-IL-00.
MANUFACTURER Abbott Laboratories, Chemical and Agricultural Products Division, North Chicago, Illinois.
DISTRIBUTION California, Indiana, Florida, Texas, Illinois.
QUANTITY 57.76 kg of bulk drug were distributed.
REASON Product failed hexane impurity level.
 

WEEK ENDING JANUARY 28

PRODUCT Quinidine Gluconate Extended Release Tablets, USP, 324 mg, in 100-tablet bottles, Rx for conversion of atrial fibrillation/flutter;
reduction of frequency of relapse into atrial fibrillation/flutter; and suppression of ventricular arrhythmias. NDC #53489-141-01.
CODE Lot #39239 EXP 8/01.
MANUFACTURER Mutual Pharmaceutical Company, Philadelphia, Pennsylvania.
DISTRIBUTION Nationwide.
QUANTITY 5,836 bottles were manufactured.
REASON Dissolution failure (12 month stability 8 hours time point).