WEEK ENDING SEPTEMBER 17

PRODUCT Timentin, Rx sterile injectable antibacterial combination a) Timentin Intravenous Infusion (Sterile Ticacillin disodium and clavulanate potassium), 31 gram, 100 cc Pharmacy Bulk Package; b) Timentin Intravenous Infusion (sterile ticarcillin disodium and clavulante potassium), 3.1 gram, in 50 cc and 100 cc vials and 50 cc ADD-Vantage units.
CODE Lot/Serial #/NDC #/EXP Date: NDC #0029-6571-26, 3.1 gram/50cc vial
KS3330 EXP 04/30/2000
KS3331 EXP 04/30/2000
KS3335 EXP 03/31/2000
KS3342 EXP 04/30/2000
KS3347 EXP 04/30/2000
KS3349 EXP 04/30/2000
KS3350 EXP 04/30/2000
KS3351 EXP 04/30/2000
KT3353 EXP 05/31/2000
KT3359 EXP 05/31/2000
KT3360 EXP 05/31/2000
KT3361 EXP 05/31/2000
KT3362 EXP 05/31/2000
KT3363 EXP 05/31/2000
KT3365 EXP 05/31/2000
KT3366 EXP 05/31/2000
KT3368 EXP 05/31/2000
KT3369 EXP 05/31/2000
KT3371 EXP 05/31/2000
KW3377 EXP 06/30/2000
KW3378 EXP 06/30/2000
KW3379 EXP 06/30/2000
NC3437 EXP 09/30/2000
NDC #0029-6571-21, 3.1 gram/100cc vial
KS3338 EXP 04/30/2000
KT3354 EXP 05/31/2000
ND3453 EXP 10/31/2000
NDC #0029-6579-21, 31 gram/100cc vial
KS3358 EXP 04/30/2000
KT3356 EXP 05/31/2000
KT3364 EXP 05/31/2000
ND3454 EXP 10/31/2000
NDC #0029-6571-40, 3.1 gram/50cc ADD-Vantage
NC3444 EXP 09/30/2000
MANUFACTURER SmithKline Beecham Pharmaceuticals, Piscataway, New Jersey.
DISTRIBUTION Nationwide and international.
QUANTITY Amount Shipped:
NDC #0029-6571-26- 819,270 bottles
NDC #0029-6571-21- 76,250 bottles
NDC #0029-6579-21- 37,330 bottles
NDC #0029-6571-40- 17,990 bottles
Firm estimated that 130,000 vials remained on market at time of recall initiation.
REASON Lack of assurance of sterility.

PRODUCT Compazine Spansule (prochlorperazine Maleate), Rx, used to control severe nausea and vomiting: a) 10 mg, in botles of 50 capsules. NDC #0007-3344-15; b) 15 mg bottles of 50 capsules and 4 capsule unit boxes. NDC #0007-3346-15 and 0007-3346-67.
CODE All lots on the market.
MANUFACTURER SmithKline Beecham Pharmaceuticals, Philadelphia, Pennsylvania.
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that 60,000 bottles of 50 capsules and 80,000 boxes of 4 capsules remained on market at time of recall initiation.
REASON Release rate failure.

PRODUCT Tenormin IV (Atenolol) 5mg/10ml ampules, Rx used for acute myocardial infarction. The product is shipped in cases of 60 ampules under the Zeneca Pharmaceuticals label. NDC 0310-0108-10.
CODE Lot Numbers: 3263B EXP 2/1/02, 3237B EXP 3/1/02, 3238B EXP 3/1/02, 3825A EXP 6/1/01, 3826A EXP 6/1/01, 3827A EXP 6/1/01, 3828A EXP 6/1/01, 3829A EXP 7/1/01, 4190A EXP 9/1/01, 4191A EXP 9/1/01, 4192A EXP 9/1/01, 8005A EXP 2/1/01, 8006A EXP 2/1/01, and 8014A EXP 3/1/01.
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY AstraZeneca, A Business Unit of Zeneca, Inc., Wilmington, Delaware
DISTRIBUTION Nationwide.
QUANTITY Firm estimated that little product remained on market at time of recall initiation.
REASON Current good manufacturing practice deviations (at contract manufacturer).

PRODUCT Cardioquin Tablets (Quinidine Polygalcturonate), 275 mg, in 100 tablet bottles, Rx used to treat significant cardiac arrhythmias. NDC #0034-5470-80.
CODE Lot #77L1 EXP 5/2004.
MANUFACTURER The P.F. Laboratories, Inc., Totowa, New Jersey (responsible firm)
RECALLED BY The Purdue Frederick Company, Norwalk, Connecticut
DISTRIBUTION Nationwide.
QUANTITY 360 bottles were distributed; firm estimated that 122 bottles remained on market at time of recall initiation.
REASON Tablet discoloration (darker-due to oxidation product).

PRODUCT MOVA brand Amoxicillin Capsules, USP, 250 mg, in 500 capsule bottles, Rx oral antibiotic. NDC #55370-884-08.
CODE Lot/Expiration: 8GM113 June 2001; Lot/Expiration: 8GM114 June 2001; Lot/Expiration: 8HM115A July 2001; Lot/Expiration: 8HM1151 July 2001.
MANUFACTURER Clonmel Health Care Ltd., Tipperary, Ireland.
RECALLED BY MOVA Laboratories, Inc., Princeton, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 17,575 Cases were distributed; firm estimated that 11,124 cases remained on market as of 7/5/99.
REASON Mislabeling - Some bottles labeled as 500 mg actually contained 250 mg capsules.

PRODUCT a) Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, in 15 mL bottles , Rx ophthalmic drug, a vasoconstrictor and mydriatic prepared as a sterile topical ophthalmic solution.(NDC 0364-736-72);
b) Artificial Tears, Lubricant Ophthalmic Solution (Polyvinyl Alcohol 1.4%), 15 mL bottles, OTC ophthalmic drug for the temporary relief of discomfort due to minor irritations of the eye (NDC 0364-2427).
CODE Lot numbers: 8H011 EXP 2/00, 8H121 EXP 2/00, 8H321 EXP 2/00, 8I231 EXP 3/00, and 8J211 EXP 3/00.
MANUFACTURER Optopics Laboratories, Division of NutraMax Products, Fairton, New Jersey.
DISTRIBUTION Nationwide.
QUANTITY 69,264 unit packages were distributed; firm estimated that 5,000 units remained on market at time of recall initiation.
REASON Unit carton mix-up - Correctly (immediate bottle) labeled Phenylephrine HCL units packaged in holding (outer) cartons labeled for artificial tears.

PRODUCT Floxin Otic Sterile (oxfloxacin otic solution), 0.3%, 5 Ml, Rx sterile anti-bacterial solution for use in the treatment of certain types of otitis media (ear infections).NDC #63395-101-05.
CODE All lot numbers (34 total) shipped prior to October 11, 1998:
Lot #: Exp. Date Lot #: Exp. Date
02228P 06/19/1999 00228P 01/22/2000
02328P 06/24/1999 00328P 01/29/2000
02428P 06/26/1999 00428P 02/05/2000
01307P 09/23/1999 00238P 02/12/2000
01407P 09/30/1999 00338P 02/17/2000
01507P 09/30/1999 00538P 03/09/2000
01607P 10/02/1999 00348P 03/19/2000
007N7P 10/08/1999 00158P 03/30/2000
008N7P 10/14/1999 00258P 04/01/2000
009N7P 10/16/1999 00658P 04/15/2000
010N7P 10/20/1999 00168P 04/17/2000
011N7P 10/22/1999 00268P 04/19/2000
00418P 12/01/1999 00178P 05/30/2000
00518P 12/01/1999 01278P 06/25/2000
00618P 12/09/1999 00188P 07/30/2000
00718P 12/11/1999 00288P 08/02/2000
00128P 01/20/2000 00388P 08/04/2000.
MANUFACTURER Parkedale Pharmaceuticals, Inc., Rochester, Michigan.
RECALLED BY Daiichi Pharmaceutical Corporation, Montvale, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 637,210 units were distributed.
REASON Leakage and lack of assurance of sterility (indentation at bottle seal)

PRODUCT Robitussin Cough & Cold Infant Drops (Guaifenesin, USP 100/ Pseudoephedrine Hydrochloride, USP 15 mg and Dextromethorphan Hydrobromide, USP 5 mg), 1 FL. OZ. (30 mL) bottle.
CODE NDC 0031-8679-01 (Commercial trade package)
Lots: EXP
9821 1/2001
9821A 1/2001
9822 4/2001
9822A 4/2001 (Contained in Infant Drops Combo 12 piece Shelf Extender, Lot 982331, shipped in cases)
9823 5/2001
9823B 5/2001
9924 7/2001
9925 8/2001
9926 9/2001
NDC 0031-8679-02 (Complimentary sample package) Lot: 9821 EXP 1/2001
MANUFACTURER A.H. Robins Company, Richmond, Virginia.
RECALLED BY Whitehall-Robins Healthcare, Madison, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 998,486 bottles were distributed.
REASON Mislabeling - dosage recommendation incorrectly states-do not exceed 6 doses in a 24 hour period, rather than the correct 4 doses in a 24 hour period.

PRODUCT Tavist D Tablets, Antihistamine/Nasal Decongestant, (Clemastine Fumarate, USP 1.34 mg/Phenylpropanolamine HCL, USP 75mg), 8 and 48 tablet units
CODE Lot numbers: 200145 EXP 10/2000 and 200146 EXP 10/2000.
MANUFACTURER Novartis Consumer Health, Inc., Lincoln, Nebraska.
DISTRIBUTION Natonwide.
QUANTITY 243,108 8-tablet packages and 40,680 48-tablet packages were distributed.
REASON Dissolution failure - Clemastine Fumarate (12 month stability test station).

PRODUCT Oxygen, Rx, USP, in high-pressure aluminum cylinders, sizes E, AA (M-6) D, and F
CODE Lot numbers:071699-2 (bulk oxygen lot #563-1959-29) 071699-3 (bulk oxygen lot #563-1959-29)
MANUFACTURER Heart of the Ozarks Medical Equipment, West Plains, Missouri.
DISTRIBUTION Missouri.
QUANTITY 19 cylinders were distributed.
REASON Incorrect lot number (bulk) on container and failure to review and approve batch production records prior to release (current good manufacturing practice deviation).

PRODUCT Diphenhydramine HCL Capsules, 25 mg, 1,000 capsule bottles, Rx, under the URL label. NDC #0677-0063-10.
CODE LOT #40977.
MANUFACTURER Mutual Pharmaceutical Company, Philadelphia, Pennsylvania.
DISTRIBUTION Indiana.
QUANTITY Firm estimated that 708 bottles remained on market at time of recall initiation.
REASON Low capsule fill weight leading to content uniformity failure.

PRODUCT Qualitest brand Q-V Tussin, Antitussive/ Decongestant/ Antihistamine Syrup,(Hydrocodone Bitartrate 2.5mg/ Pseudoephedrine HCL 30mg/ Chlorpheniramine Maleate 2 mg), Rx in 1 pint (473 mL) bottles. NDC #0603-1609-58.
CODE LOT #006H7A EXP 8/99.
MANUFACTURER Vintage Pharmaceuticals, Inc., Huntsville, Alabama.
DISTRIBUTION Nationwide.
QUANTITY 7,748 bottles were distributed.
REASON Subpotency (stability) for the chlorpheniramine maleate ingredient.
 

WEEK ENDING SEPTEMBER 24

PRODUCT Merrem (Meropenem for Injection), used for intra-abdominal infections and bacterial meningitis: a) 500 mg in 20 ml and 100 ml vials; b) 1 gram in 30 ml, and 100 ml vials, and in 15 ml ADDVantage vials. NDCs 0310-0325-11 (100 ml vial/500 mg), 0310-0325-20 (20 ml vial/500 mg), 0310-0321-11 (100 ml vial/1 gram), 0310-0321-15 (15 ml vial/1 gram), and 0310-0321-30 (30 ml vial/1 gram).
CODE The expiration period for all lots is 8/99 - 11/01. The lot numbers are as follows:
500 mg lots: 4082Y, 3105A, 3192B, 3193B, 3625A, 3720Y, 4083Y, 4103A, 4323A, 4419Y, 4695A, 4722A, 4777A, and 4778A.1 gram lots: 3210Y, 3228Y, 3869Y, 4409Y, 3099A, 3912A, 4410Y, 4804Y, 3101A, 3102A, 3103A, 3107A, 3108A, 3176B, 3178B, 3179B, 3180B, 3182B, 3183B, 3184B, 3190B, 3191B, 3212Y, 3213Y, 3214Y, 3621A, 3622A, 3717Y, 3913A, 3914A, 3915A, 4078Y, 4078Y, 4080Y, 4081Y, 4100A, 4101A, 4321A, 4322A, 4324A, 4325A, 4413Y, 4414Y, 4415Y, 4719A, 4733A, 4734A, and 4806Y.
MANUFACTURER Marsam Pharmaceuticals, Inc., Cherry Hill, New Jersey.
RECALLED BY AstraZeneca, a business unit of Zeneca, Inc., Wilmington, Delaware
DISTRIBUTION Nationwide and Canada.
QUANTITY Approximately 2,500 cases remained on market at time of recall initiation.
REASON Current good manufacturing practice deviations (at contract manufacturer).

PRODUCT Acyclovir Tablets, Rx oral antiviral drug for the acute treatment of herpes zoster, initial episodes and management of recurrent episodes of genital herpes, and the treatment of chickenpox, packaged in unit dose and bottles of 100 and 500 tablets under the following labels:
a) 400 mg. Tablets:
i) 100 tablets/unit dose, NDC #51079-877-20, Distributed by UDL Laboratories, Inc., Rockford, IL;
ii) 100 tablet bottle, NDC #55953-943-40;
iii) 500 tablet bottle, NDC #55953-943-7;
b) 800 mg. Tablets:
i) 100 tablets/unit dose, NDC #51079-878-20, Distributed by UDL Laboratories, Inc., Rockford, IL;
ii) 100 tablet bottle, NDC #55953-947-40;
iii) 500 tablet bottle, NDC #55953-947-70.
CODE The following lot numbers will be followed with letter sublot designations, i.e. 113569A, on the package labels:
a) 400 mg.: 113569, 108227
b) 800 mg.: 108235, 108772, 113570, 113571, 113572.
MANUFACTURER Novopharm Ltd., Toronto, Ontario, Canada.
RECALLED BY Novopharm USA, Inc., Schaumburg, Illinois
DISTRIBUTION Nationwide.
QUANTITY 2,212 unit dose cartons, 105 500-tablet bottles and 12,737 100-tablet bottles of 400 mg. tablets and 1,602 unit dose cartons, 759 500-tablet bottles and 8,838 100-tablet bottles of 800 mg. tablets were distributed; firm estimates that 40% of the product remains on the market.
REASON Softening and cracking of tablets.