WEEK ENDING FEBRUARY 11

PRODUCT Adenoscan (r) Adenosine (90 mg/30 mL), in 30 mL single-dose vial, for intravenous infusion only, Rx intravenous infusion nucleoside vasolidator used as an adjunct to thallium-201 myocardial perfusion scintigraphy in patients unable to exercise adequately.
CODE Lot Numbers: 190244, 190249, 190258, 190613, 190665 and 190677.
MANUFACTURER American Pharmaceutical Partners, Inc (APP), Melrose Park, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 275,151 vials were distributed; FDA estimated that 100,000 vials remained on the market at time of recall initiation.
REASON Chipped and leaking vials - Possible presence of glass particles in vials.

PRODUCT Cyndal HD Cough Syrup (Hydrocodone Bitartrate 1.57mg/ Phenylephrine Hydrochloride 5mg/Chlorpheniramine Maleate 2mg), in 16 fluid ounce and 1 gallon containers. NDC 60258-703-16 (16 oz) and 60258-703-28 (1 gallon).
CODE Lot #91949.
MANUFACTURER Great Southern Laboratories (GSL), Houston, Texas.
DISTRIBUTION Southeastern United States.
QUANTITY 118 gallon bottles and 7,032 pint bottles were distributed.
REASON Subpotency of the phenylephrine (50%) due to incorrect weight addition in batch production.

PRODUCT Esgic-Plus? Tablets (butalbital 50mg, acetaminophen 500mg, caffeine 40mg), in 100 tablet bottles. NDC #0456-0618-01.
CODE Lot #90248A 1 EXP 8/01.
MANUFACTURER Med-Pro, Inc., Lexington, Nebraska (repacker/responsible firm).
DISTRIBUTION New York.
QUANTITY 999 bottles were distributed.
REASON Mislabeling - Bottles contain capsule form of the same ingredient product; not the labeled tablet form of product.

PRODUCT Neomycin and Polymyxin B Sulfates and Hydrocortisone OTIC Solution, USP, Rx, 3.5mg/10,000 units/10mg (1%), 10 mL with sterile dropper.
CODE Lot #205101 EXP 4/01.
MANUFACTURER Bausch and Lomb Pharmaceuticals Inc., Tampa, Florida.
DISTRIBUTION Nationwide.
QUANTITY 45,808 units were distributed.
REASON One unit was found to contain Hydrocortisone Otic Suspension not Hydrocortisone Solution as labeled.
 

WEEK ENDING FEBRUARY 25

PRODUCT Zen Liquid (1,4-Butanediol), in 35-fluid ounce bottles, OTC intended to be used as a sleep aid.
CODE All Lot Numbers.
MANUFACTURER Science Enhancement Systems, Inc., Delray Beach, Florida.
DISTRIBUTION Nationwide.
QUANTITY Approximately 5,400 bottles were distributed.
REASON Product is an unapproved new drug.

PRODUCT Extra Strength Panadol PM Caplets, (500 mg Acetaminophen, 25 mg Diphenhydramine HCL), OTC, in bottles of 36 and 50 caplets and dispenser cartons of two caplets per pack.
CODE Lot Numbers: PA033SH1 PA033SH2 PA027SJ2 PA083SH1 PA034SH1 PA035SH1 PA098SH1 PA036SH1 PA032SH1 PA027SJ4 PA028SJ1. EXP date for all lots: 07/2001.
MANUFACTURER SmithKline Beecham, Dungarvan Ltd., Count Waterford, Ireland.
RECALLED BY SmithKline Beecham, Consumer Health, Parsippany
DISTRIBUTION Puerto Rico.
QUANTITY 171,850 caplets were distributed.
REASON Glass particles were found in bulk diphenhydramine used in manufacturing.

PRODUCT a) Solu-Medrol Methylprednisolone sodium succinate for injection, USP, 500 mg, single dose vial, 4 mL, sterile powder, b) Solu- Cortef Hydrocortisone sodium succinate for injection, USP, 100 mg, 2mL, Single dose vial, sterile powder, c) Solu-Cortef Hydrocortisone sodium succinate for injection, USP, 500 mg, 4 mL, Single dose vial, sterile powder,
CODE a) NDC 0009-0765-02. Lots 02DAF and 23DAM EXP 3/31/01. b) NDC 0009-0900-20. Lot 29DAM EXP 3/31/04 NDC 0009-0900-13. Lot 48DCU EXP 6/30/04 NDC 0009-0912-05. Lots 51DCU and 52DCU EXP 6/30/04 c) NDC 0009-0912-05. Lots 51DCU and 52DCU EXP 6/30/04.
MANUFACTURER Pharmacia & Upjohn, Kalamazoo, Michigan.
DISTRIBUTION Nationwide, Bahamas, Cayman Islands, Colombia, Japan.
QUANTITY 261,258 vials were distributed.
REASON Lack of assurance of sterility.