WEEK ENDING SEPTEMBER 15

PRODUCT Sodium Bicarbonate Injection, USP, 8.4% (84 mg/mL), for IV use only, in 50 mL single dose vial, Rx for correction of metabolic acidosis and other conditions requiring systemic alkalization
CODE Lot #190365 EXP 11/00.
MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 37,500 vials were distributed; firm estimated that little if any remains on the market.
REASON Lack of assurance of sterility (particle counts exceeding action level).

PRODUCT Synercid(r) I.V. (Quinupristin and Dalfopristin for injection), 500 mg, in 10 mg single dose vial, lyophilized, Rx indicated for the treatment of patients with serious or life-threatening infections associated with vancomycin-resistant Enterococcus faecium (VREF) bacteremia.
CODE
9G1439     9G1471     9H1854     9J2122     0A1297
9G1440     9G1438     9H1855     9L2562     0A1316
9G1470     9G1441     9H1853     0A1298     0A1419.
MANUFACTURER Catalytica Pharmaceuticals, Inc., Greenville, North Carolina.
RECALLED BY Aventis Pharmaceuticals, Inc., Kansas City, Missouri
DISTRIBUTION Nationwide, Spain, Canada.
QUANTITY 582,130 vials were distributed.
REASON Lack of assurance of sterility (seal integrity).

PRODUCT SangCya(tm) Oral Solution (Cyclosporine Oral Solution, USP Modified), 100 mg/mL, Rx indicated for the prophylaxis of organ rejection in kidney, liver, and heart allogeneic transplants; for severe active, rheumatoid arthritis where treatment with methotrexate is not adequate; and for the treatment of adult nonimmunocompromised patients with severe, recalcitrant, plaque psoriasis who have failed to respond to at least one systemic therapy.
CODE
LOT # EXP DATE
2MG69M-------- 06/01/99
1NC30P-------- 01/01/00
1NG00M-------- 04/01/00
1NE00N-------- 03/01/00
2MH05N-------- 05/01/00
2MH06M-------- 07/01/00
2MH06MA------ 01/01/01
2MH07M-------- 08/01/00
2MH07MA------- 02/01/01
2MH04N-------- 05/01/00
2MH52M-------- 08/01/00
2MH52MA------- 02/01/01
2MH53M-------- 08/01/00
2MR63N-------- 02/01/01
2MR64N- ------ 02/01/01
2ND22M-- ----- 04/01/01
2ND22MA------- 10/01/01
2NE50M-------- 04/01/01.
MANUFACTURER Eli Lilly and Company, Indianapolis, Indiana.
RECALLED BY SangStat Medical Corporation, Fremont, California
DISTRIBUTION Nationwide, United Kingdom, Germany, Hong Kong, Israel.
QUANTITY 15,418 bottles were distributed.
REASON Bioequivalence - Product is not bioequivalent when taken with apple juice.

PRODUCT Butyl-P-Aminobenzoate Injection, (Butamben (2.5% (25 mg/mL), in Methocel E-4, 1%, 10 mL amber vials, Rx compounded parenteral drug.
CODE 0400060, 0400052, 0500130.
MANUFACTURER Medical Center Pharmacy, Fort Worth, Texas.
DISTRIBUTION Texas.
QUANTITY 17 bottles were distributed.
REASON Misbranding - Product on withdrawn list for compounding.

PRODUCT Etoposide Injection, USP, 20 mg/mL, (100mg/mL), 5 mL multiple dose vial, Rx used in the management of refractory testicular tumors and small cell lung cancer, and must be diluted before I.V. infusion.
CODE Lot #100006 EXP 01/02.
MANUFACTURER American Pharmaceutical Partners, Inc., Melrose Park, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 12,021 vials were distributed.
REASON Misbranding - Some vial cartons are missing printed text.

WEEK ENDING SEPTEMBER 22

PRODUCT a) Digoxin Injection USP 0.25 mg per ml, 1 ml Tubex cartridge, 10 cartridges per package; 60 cartridges per case, is used to treat heart failure, atrial fibrillation and atrial flutter.
b) Dimenhydrinate Injection USP 50 mg per ml, 1 ml Tubex cartridge, 10 cartridges per package; 60 cartridges per case. The product is used to prevent and treat nausea, vomiting, or vertigo related to motion sickness.
c) Diphenhydramine HCl Injection USP 50 mg per ml, 1 ml Tubex cartridge, 10 cartridges per package; 60 cartridges per case. The product is used to treat motion sickness and is consider an antihistamine and antiparkinson drug.
CODE Lot Numbers: a) 4990194 exp. 5/01; b) 49990197 exp. 10/01; c) Lot 49990052 exp. 2/02.
MANUFACTURER Wyeth Ayerst Laboratories, Marietta, Pennsylvania.
DISTRIBUTION Nationwide and Puerto Rico.
QUANTITY a) 40,470 tubexes; b) 70,370 tubexes; c) 40,900 tubexes were distributed.
REASON Tubex(r) cartridges may be cracked or chipped.

PRODUCT Cephradine Capsules, USP, 500 mg, in 100-count bottles, Rx indicated in the treatment of respiratory tract infections, otitis media, skin and skin-structure infections, and urinary tract infections.
CODE Lot Numbers 57450 EXP 9/00 and 57988 EXP 6/01.
MANUFACTURER Teva Pharmaceuticals USA, Fairfield, New Jersey.
RECALLED BY Teva Pharmaceuticals USA, Sellersville, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY 10,244 units of lot 057450 and 1,755 units of lot 057988 were distributed; firm estimated that 5 percent of product remained on market at time of recall initiation.
REASON Subpotency (stability).

PRODUCT Nitroglycerin Sublingual Tablets, 0.4 mg, in 25 and 100-count amber glass bottles.
CODE
N419R1 (25 tablets each) NDC 60951-718-25
N419W1 (25 tablets each) NDC 60951-718-25
N459W1 (100 tablets each) NDC 60951-718-70.
MANUFACTURER Konec Limited Liability Company, Tucson, Arizona.
DISTRIBUTION Pennsylvania.
QUANTITY N419R1: 8,891 bottles of 25 tablets each
N419W1: 16,726 bottles of 25 tablets each
N459W1: 4,719 bottles of 100 tablets each.
REASON Metal particle contamination.

PRODUCT Target Non-Aspirin Pain Reliever Tablets, in 500-count bottles, OTC pain reliever.
CODE Lot #8N00527 EXP 11/01.
MANUFACTURER Leiner Health Products, Inc., Kalamazoo, Michigan.
RECALLED BY Lenier Health Products, Inc., Carson, California
DISTRIBUTION Minnesota, Arizona, California, Colorado, Georgia, Wisconsin, Oregon, Indiana, Virginia, Texas.
QUANTITY 400 cases (6 bottles per case) were distributed; firm estimates none remains on the market.
REASON Product mix-up - Presence of buffered aspirin (325 mg) in some bottles.

PRODUCT Augmentin(r) Oral Suspension (Amoxicillin 400mg/Clavulanate Potassium 57 mg), 400 mg/5mL, in 100 mL multi-dose bottles. PAR
CODE Lot #MR2754 EXP 2/01.
MANUFACTURER SmithKline Beecham Pharmaceuticals, Bristol, Tennessee.
RECALLED BY SmithKline Beecham Pharmaceuticals, NA Philadelphia, Pennsylvania
DISTRIBUTION Nationwide.
QUANTITY 59,940 units were distributed.
REASON Subpotency of Clavulanic Acid (9 month stability station).

PRODUCT Leucovorin Calcium Injection, USP, 500mg/50ml single dose vial, Rx drug product in an amber glass vial.
CODE LOT #99K202 EXP 08/2001.
MANUFACTURER Gensia Sicor Pharmaceuticals, Inc., Irvine, California, by letter on August 18, 2000. Firm-initiated recall ongoing.
DISTRIBUTION Alabama, Florida, Georgia, Illinois, Kentucky, Massachusetts, Maryland, Maine, Michigan, Missouri, Mississippi, North Carolina, New Hampshire, New Jersey, New York, Ohio, Pennsylvania, South Carolina, Tennessee, Wisconsin, West Virginia, District of Columbia.
QUANTITY 13,132 vials were distributed.
REASON Particulates (stability).

PRODUCT Vicodin(r) Tablets (Hydrocodone bitartrate 5 mg and Acetaminophen 500 mg), in 500 count bottles, Rx indicated for the relief of moderate to moderately severe pain.
CODE
NDC Number Lot Number EXP Date Bottle Size
0044-0727-03 1076-0418 09/2002 500 count
0044-0727-03 1076-0428 09/2002 500 count
0044-0727-03 1076-0438 09/2002 500 count.
MANUFACTURER Knoll Pharmaceutical Company, Whippany, New Jersey.
RECALLED BY Knoll Pharmaceutical Company, Mount Olive, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 8,222 bottles were distributed; firm estimates none remains on the market.
REASON Dissolution failure.

PRODUCT Tri-Nasal (Triamcinolone acetonide, USP) Nasal Spray, 50 mcg, 15 mL, 120 metered sprays, Rx indicated for the treatment of nasal symptoms of seasonal and perennial allergic rhinitis in adults and children older than 12 years of age.
CODE Lot Numbers: 00305 EXP 11/01, 00306 EXP 12/01, 00105, 00205, 00406 and 00506, all EXP 11/02 (physician samples).
MANUFACTURER Muro Pharmaceutical, Inc., Tewksbury, Massachusetts.
DISTRIBUTION Nationwide.
QUANTITY 134,138 units were distributed.
REASON Leaking containers.

PRODUCT Leukeran(r) (chlorambucil) Tablets, 2 mg, in 50-count bottles, Rx.
CODE Lot 0A1387
MANUFACTURER Glaxo Wellcome, Inc., Zebulon, North Carolina.
DISTRIBUTION Nationwide and Canada.
QUANTITY 36,463 units were distributed.
REASON Impurity specification failure (stability).

PRODUCT Levsinex(tm) Capsules (Hyoscyamine Sulfate, USP), 0/375 mg, Timecap Extended Release, Rx for use as adjunctive therapy in the treatment of peptic ulcer.
CODE Lot #02580K EXP 2002.
MANUFACTURER Schwarz Pharma, Seymour, Indiana.
RECALLED BY Med-Pro, Inc., Lexington, Nebraska
DISTRIBUTION New York.
QUANTITY 299 bottles were distributed.
REASON Insert incorrectly states product has a clear capsule body and contains beadlets, product actually has a white capsule body and contains a tablet

PRODUCT Methocarbamol, USP, bulk active ingredient powder, Rx formulated to produce a muscle relaxant.
CODE Lot Numbers: 00952 and 00949.
MANUFACTURER Boehringer Ingelheim Chemicals, Inc., Petersburg, Virginia.
DISTRIBUTION Canada.
QUANTITY 2,124.7 kg of product was distributed.
REASON Contamination with polypropylene fibers.

PRODUCT DesOwen(r) Cream (Desonide Cream), 0.05%, 60g tube.
CODE Lot # PGCN.
MANUFACTURER DPT Laboratories, Inc., San Antonio, Texas.
RECALLED BY Galderma Laboratories LP, Fort Worth, Texas
DISTRIBUTION Nationwide.
QUANTITY 4,920 units in 410 shipping containers were distributed.
REASON Mislabeling - Shipping cases were incorrectly labeled as containing ointment not cream form of product.

PRODUCT Aluminum Hydroxide Gel, USP, Antacid, 320 mg/5mL, mint flavor, in 12 and 16-fluid ounce bottles.
CODE Lot Numbers: 9I13 and 9I11.
MANUFACTURER Pharmaceutical Associates, Inc., Greenville, South Carolina.
DISTRIBUTION Nationwide.
QUANTITY 6,000 16-ounce and 8,359 12-ounce bottles were distributed.
REASON Resuspension problems.
 

WEEK ENDING SEPTEMBER 29

PRODUCT Glucose Tolerance Test Beverage, (Carbonate), Cola, Lemon Sour, and Orange Flavors, 100 gms D-Glucose, in 10-fluid ounce bottles, under the brand Qualadex, OTC used as a diagnostic test solution for diabetes testing.
CODE All lots manufactured on or after August 1999.
MANUFACTURER Irenda Corporation, Los Angeles, California (contract manufacturer)
RECALLED BY Breen Labs, Los Angeles, California (responsible firm/distributor)
DISTRIBUTION California.
QUANTITY 44,231 bottles were distributed.
REASON Sub-potency.

PRODUCT Carbamazepine Tablets, 200 mg, Rx.
CODE Lot #S302QJ EXP 10/31/01.
REPACKER Pharmaceutical Corporation of America, Carmel, Indiana.
DISTRIBUTION Virginia.
QUANTITY 4,532 bottles were distributed; firm estimates none remains on the market.
REASON Label mix-up - A portion of the lot was labeled as tetracycline 500 mg.

PRODUCT 649 various Rx and OTC products.
CODE All products and package sizes bearing a PCA (Pharmaceutical Corporation of America) label except those with a lot number ending in RA, RB, or RC.
REPACKER Pharmaceutical Corporation of America, Carmel, Indiana.
DISTRIBUTION Nationwide.
QUANTITY 3,846,600 bottles were distributed.
REASON Current good manufacturing deviations, including but not limited to lack of control to prevent beta-lactam antibiotic cross contamination.

PRODUCT Homatropine Hydrobromide Ophthalmic Solution, USP, 5% Dropperettes, 1 ml, Rx for treatment of itritis an diridocyclitis, for relief of cillary spasm, and also as an aid in refraction.
CODE Lot Numbers and EXP Dates: W152 AUG-00, X2123 MAR-01, X2124 AUG-01, X2125 AUG-01, X2126 SEP-01, X2127 SEP-01, X2128 OCT-01, X2129 OCT-01.
MANUFACTUER OMJ Pharmaceuticals (OMJ), San German, Puerto Rico.
RECALLED BY Ciba Vision Ophthalmic (CVO), Duluth, Georgia (distributor of finished product, responsible for labeling text)
DISTRIBUTION Puerto Rico.
QUANTITY 8,229 units were distributed.
REASON Potency not within USP specifications (stability).