OCTOBER
2001
WEEK ENDING OCTOBER 20
PRODUCT AND CODE: Pulmolite, a kit for the
preparation of Technetium Tc99m Albumin Aggregated for Injection, labeled as
sterile and non-pyrogenic, Rx, for diagnostic use. Codes: Lot Number 127254; Expiration
Date 01 AUG 02.
REASON: Lack of assurance of sterility (crimp seal
problems).
MANUFACTURER: Ben Venue Laboratories, Inc. Bedford, OH.
RECALLED BY: CIS-US, Inc., Bedford, MA
DISTRIBUTION: Nationwide
QUANTITY: 33,475 vials
PRODUCT AND CODE: Etrafon Tablets,USP, brand
of perphenazine and amitriptyline hydrochloride, each tablet contains
perphenazine, USP 2 mg, and amitriptyline hydrochloride, USP 25mg,100 tablet
bottles and 100 tablets packaged unit dose, Rx only.
Codes:
Lot No: 9-ANC-1, Exp. Date September 2001
REASON: Dissolution Failure (18 Month Stability)
MANUFACTURER/RECALLING FIRM: Schering Corp Kenilworth,
NJ
DISTRIBUTION: Nationwide
QUANTITY: 15,477 bottles of 100 and 2,220 unit dose blisters
in boxes of 100
PRODUCT AND CODE: Nitro Tab (Nitroglycerin
Tablets, USP) 0.3mg (1/200 gr), Rx Only, 100 Sublingual tablets, Lot 021002,
bottles of 100's. Codes: Lot 012002,
Exp. 12/2002.
REASON: Mislabeled:
0.3 MG Product Labeling
(Exterior Carton ) incorrectly declares bottles to contain 0.4 MG. tablets.
MANUFACTURER/RECALLING FIRM: Able Laboratories, South
Plainfield, NJ
DISTRIBUTION: OH
QUANTITY: 1260/100 tablet bottles
PRODUCT AND CODE: Levoxyl(Levothyroxine
Sodium Tablets,USP) 25 mcg (0.025 mg)100 and 1000 tablet bottles, Rx only; Levoxyl(Levothyroxine
Sodium Tablets,USP) 150 mcg (0.15 mg)100 tablet bottles, Rx only Codes: 25mcg:
Lot number 6413, Exp 12/2001
150mcg:
Lot number 6294, Exp 11/2001
REASON: Subpotency (During Stablity)
MANUFACTURER: King Pharmaceuticals, St. Petersburg, Fl.
(formerly Daniels Pharmaceuticals), St. Petersburg, FL
RECALLED BY: King Pharmaceuticals, Inc. Bristol, TN
DISTRIBUTION: Nationwide
QUANTITY: 19,390 units of lot 6413 and 37,882 units of lot
6294
PRODUCT AND CODE: Oxygen USP, compressed,
sold in high pressure cylinders of size E. Codes:297 cylinders were involved in
the recall to two consignees. The lot numbers are:
016ORL1018A
016ORL1018D
022ORL1018F
357ORL0018C.
REASON: Misbranded: Cylinders were shipped empty or
partially filled.
MANUFACTURER: Air Liquide America Orlando, FL
RECALLED BY: Air Liquide America Corp Houston, TX
DISTRIBUTION: FL
QUANTITY: 297
PRODUCT AND CODE: Motion Sickness (Meclizine
HCl 25 mg) Tablets, 8 Tablet cartons, Non-prescription (OTC).
Codes:
PL Developments lots: 2193, J1931, J1932, exp. 4/2002 PDK bulk lot: 00D388.
Longs
NDC: 12333-9831-1
Eckerd
NDC: 19458-039-51
Discount
Drug Mart-Food Fair barcode #: 933351 10978
Valu-Rite
NDC: 49348-363-67
REASON: Dissolution Failure
MANUFACTURER/RECALLING FIRM: PDK Labs of Hauppauge, NY
DISTRIBUTION: CA, FL and OH
QUANTITY: 34,782 blistered units (8 tablets per blister)
PRODUCT AND CODE: Etodolac Capsules, USP,
200 mg, Rx only, 100 Capsule bottles
Codes: Lot 014430, expiration date
5/2003,
NDC 51672-4016-1, ANDA #75-078.
REASON: Misbranded: Product label incorrectly declares
product as tablets.
MANUFACTURER: Taro Pharmaceutical Industries Ltd. Haifa
Bay, Israel,
RECALLED BY: Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY
DISTRIBUTION: PA and KY
QUANTITY: 1582 bottles (100s)
PRODUCT AND CODE: Women's Tylenol Menstrual
Relief Caplets. The OTC Product is 500 mg acetaminophen and 25 mg pamabron film
coated caplets. The product is sold in 40 count bottles. Codes: Lot DJM099 exp.
9/02
REASON: Dissolution Failure - Acetaminophen component
(STABILITY)
MANUFACTURER: McNeil Consumer Healthcare Guelph, Ontario,
Canada
RECALLED BY: McNeil Consumer Healthcare, Fort
Washington, PA
DISTRIBUTION: Nationwide
QUANTITY: 133,296 bottles
PRODUCT AND CODE: Sentry Simethicone
Emulsion USP, (30% Active) in 40 pound pails and 425 pound drums,Bulk
pharmaceutical, OTC
Codes:
Batches 248450, 248451, 248453, 248454, 248455, all expire 10/2002
REASON: Failed USP Defoaming Test.
MANUFACTURER/RECALLING FIRM: Crompton Corporation/OSI
Specialties Friendly, WV
DISTRIBUTION: NY, OH, NJ, MO, Fl
QUANTITY: 13,085 lbs