NOVEMBER 2003

 

WEEK ENDING NOVEMBER 1


PRODUCT
a) Zyprexa Tablets (Olanzapine), 5 mg, 60 tablet bottles, Rx only.
b) Zyprexa Tablets (Olanzapine), 10 mg, 60 tablet bottles, Rx only.
c) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles, Rx only.
d) Zyprexa Tablets (Olanzapine), 20 mg, 60 tablet bottles, Rx only.

CODE
a) Lot Number: 6AA66A;
b) Lot Numbers/Exp. Date: 6AH19A (01/05), 7AA39A (03/05), and 7EA97A (04/05);
c) Lot Numbers/Exp. Date: 6AH35A (01/05), 6AG70A (11/04);
d) Lot Numbers: 7EC85A and 7AA79A.
RECALLING FIRM  Walsh Heartland, LLC, Paragould, AR.
MANUFACTURER--Unknown
REASON Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 547 bottles.
DISTRIBUTION Nationwide.


PRODUCT
a) Zyprexa Tablets (Olanzapine), 10 mg, 60 tablet bottles, Rx only. 
b) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles, Rx only.
CODE
a) Lot No./Exp. Date: 6AH19A (Exp. 01/05), 7AA39A (Exp. 03/05), 7EA97A (Exp. 04/05).
b) Lot No./Exp. Date: 6AH35A (Exp. 01/05) and 6AG70A (Exp. 11/04).
RECALLING FIRM R&L Associates of Walled Lake, LLc, Walled Lake, MI.
MANUFACTURER--unknown
REASON Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE Unknown
DISTRIBUTION Nationwide.


PRODUCT
a) Zyprexa Tablets (Olanzapine), 5 mg, 60 tablet bottles, Rx only. 
b) Zyprexa Tablets (Olanzapine), 10 mg, 60 tablet bottles, Rx only.
CODE
a) Lot # 6AA66A;
b) Lot # 6AH19A.
RECALLING FIRM Houston Rx, Inc., Humble, TX.
MANUFACTURER--unknown
REASON Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 45 bottles.
DISTRIBUTION Nationwide.


PRODUCT Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains: Lopinavir 133.3mg, Ritonavir 33.3mg, 180 capsule bottles, Rx only.
CODE Lot No. 852072E25.
RECALLING FIRM The Harvard Drug Group, Livonia, MI.
MANUFACTURER--unknown
REASON Counterfeit: bottles labeled as containing Kaletra capsules may contain Kaletra capsules and/or Agenerase capsules or a mix of both, as well as, bottles of Kaletra capsules have been repackaged/relabeled by an unknown source with an extended expiration date/counterfeit lot number.
VOLUME OF PRODUCT IN COMMERCE 71 bottles.
DISTRIBUTION Nationwide.

 

WEEK ENDING NOVEMBER 8

 

PRODUCT Tegretol tablets (Carbamazepine USP), 200 mg, 1000 tablet bottles. Rx only. 
CODE Lot 218D8264.
RECALLING FIRM/MANUFACTURER Novartis Pharmaceuticals, Corp.
REASON Dissolution failure; stability (at 30-months).
VOLUME OF PRODUCT IN COMMERCE 3,622 bottles.
DISTRIBUTION Nationwide


PRODUCT
a) Zyprexa tablets (olanzapine), 5 mg, 60 tablet bottles, Rx only.
b) Zyprexa tablets (olanzapine), 10 mg, 60 tablet bottles, Rx only. 
CODE
a) 6AA66A;
b) 6AH19A.
RECALLING FIRM/MANUFACTURER Recalling Firm: Rochester Drug Cooperative Inc., Rochester, NY.
Manufacturer: Unknown.
REASON Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 500 (est) bottles.
DISTRIBUTION Nationwide.


PRODUCT Zyprexa tablets (olanzapine), 20 mg, 60 tablet bottles, Rx only.
CODE  Lot No. 7AA79A, Exp. 3/1/05.
RECALLING FIRM/MANUFACTURER Recalling Firm: Rochester Drug Cooperative Inc, Rochester, NY.

Manufacturer: Unknown.
REASON  Counterfeit : An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE  12 bottles.
DISTRIBUTION Nationwide.


PRODUCT Lipitor tablets (Atorvastatin Calcium),10 mg, Rx only, 5000 TABLETS. Important - This package for pharmacy stock use.
CODE Lot 16092V (exp. date 7/2004), QK Item # 64953.
RECALLING FIRM/MANUFACTURER Recalling Firm: QK Healthcare, Inc., Ronkonkoma, NY.
Manufacturer: Unknown.
REASON Counterfeit: An unknown number of units bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE  20 bottles of 5000 Tablets.
DISTRIBUTION TX.


PRODUCT Kaletra Capsules (Ritonavir/Lopinavir 33.3mg/133.3mg), 180 capsule bottles, Rx only.
CODE Lot 852002E21, EXP 1 FEB 2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Mid Atlantic Csc, Perryman, MD.
Manufacturer: Unknown
REASON  Counterfeit : An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 71 bottles.
DISTRIBUTION Nationwide.


PRODUCT Kaletra capsules (lopinavir/ritonavir), 133.3/33.3mg, 180 capsule bottles, Rx Only. 
CODE  Lot No. 852072E25 (Exp. 1JUN2004) and Lot No. 852002E21 (Exp. 12/03 or 02/04).
RECALLING FIRM/MANUFACTURER Recalling Firm: Midwest Drug Supply LLC.
Manufacturer: Unknown
REASON Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 387 bottles.
DISTRIBUTION Nationwide.


PRODUCT Sufenta Injection, (Sufentanil Citrate), 50 mcg/mL (Sufentanil base),1 mL and 5 mL ampules, 10 ampules per carton; Rx Only.
CODE Lot Number-1 mL ampule, 11522, Exp. 1/4 and 5 mL ampule, 11192, Exp. 01/04.
RECALLING FIRM/MANUFACTURER Akorn, Inc., Decatur, IL
REASON Unapproved New Drug; These lots were manufactured with an active ingredient produced according to a drug master file method not cited in the approved New Drug Application.
VOLUME OF PRODUCT IN COMMERCE  24,460 ampules.
DISTRIBUTION Nationwide and Puerto Rico.

 

PRODUCT Senokot-S tablets (Sennosides 8.6 mg and Docusate Sodium 50 mg) tablets, 30 count bottles.
CODE Lot No. PB11.
RECALLING FIRM/MANUFACTURER The Purdue Frederick Company, Stamford, CT.
REASON Subpotent (Sennosides).
VOLUME OF PRODUCT IN COMMERCE 45,420/30 count bottles.
DISTRIBUTION Nationwide.


PRODUCT  MORPHINE-SULFATE EXTENDED-RELEASE TABLETS, 15 mg, 100 TABLETS, Rx only, ENDO GENERIC PRODUCTS.
CODE Lot TP168A, Exp. date 2/2006.
RECALLING FIRM/MANUFACTURER Recalling Firm: Endo Pharmaceutical, Inc., Garden City, NY.
Manufacturer: Bristol-Myers Squibb Company Princeton, New Jersey.
REASON Mis-labeling: some tablets are not imprinted with an identification number, bearing the number "15" on each side. (Each tablet should be imprinted with the number "15" on one side and with the identification code "E652" on the other side).
VOLUME OF PRODUCT IN COMMERCE  22,608 bottles of 100s.
DISTRIBUTION Nationwide.

***CORRECTION***
Morphine-Sulfate Extended-Release Tablets. The manufacturer is listed as Bristol-Myers Squibb in Princeton, NJ but this product/lot was actually made by Bristol-Myers Squibb in Garden City, NY.

 

WEEK ENDING NOVEMBER 15


PRODUCT Lipitor tablets (Atorvastatin Calcium), 10 mg, Rx only, 5,000 tablet bottles, Important - This package for pharmacy stock use.
CODE Lot # 16092V.
RECALLING FIRM/MANUFACTURER Recalling Firm: Valley Drug Company, Inc., Youngstown, OH.
Manufacturer: Unknown.
REASON Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 20 bottles of 5,000 tablets each.
DISTRIBUTION NY.


PRODUCT ProHance injection, pre-filled single dose syringes (gadoteridol injection), 279.3mg/mL, 10mL and 17mL syringes.
CODE

Lot Number      Exp. Date          Syringe Fill Volume 10 or 17 mL.

3A24160            1/31/2006          17

2L22102             12/31/2005        17

2K21712            11/30/2005        17

2J21003              10/31/2005        17

2I32955              9/30/2005          17

2I17317              9/30/2005          10

2H16614            8/31/2005          17

2H15874            8/31/2005          17

2F17315             6/30/2005          10

2F12961             6/30/2005          17

2C08707             3/31/2005          17

2B07323             2/28/2005          17

2B07322             2/28/2005          17

2B06887             2/28/2005          17

2B06354             2/28/2005          10

2B06353             2/28/2005          10

2B05899             2/28/2005          17

1J00355              10/31/2004        17

1I22325              9/30/2004          17

1H20014            8/31/2004          17

1G19656             7/31/2004          17

1G19572             7/31/2004          17

1G18241             7/31/2004          17

1G18456             7/31/2004          10

1G17795             7/31/2004          17

1D17792            4/30/2004          17

RECALLING FIRM/MANUFACTURER Bracco Diagnostic Inc., Princeton, NJ.
REASON Lack of assurance of sterility; Tip caps on pre-filled syringes have been observed with cracks in the area where they contact the syringe barrel.
VOLUME OF PRODUCT IN COMMERCE 255,095 syringes.
DISTRIBUTION Nationwide.


PRODUCT INDOMETHACIN Capsules, 25 MG, 60 capsule plastic bottles, RX ONLY.
CODE Lot # 2I3981BB EXP 7/2004.
RECALLING FIRM/MANUFACTURER Recalling Firm: Direct Dispensing, Inc., Miami, FL.
Manufacturer: Mylan Pharamceuticals, Morgantown, WV.
REASON Label Mix-up: bottles labeled as containing 25 mg strength capsules actually contain 50 mg capsules.
VOLUME OF PRODUCT IN COMMERCE 400 bottles.
DISTRIBUTION Nationwide.


PRODUCT
a) Estrace tablets (estradiol tablets, USP) 0.5mg, physician samples, 7 and 21 count boxes, Rx Only, NOT AN ORAL CONTRACEPTIVE.
b) Estrace tablets (estradiol tablets, USP) 1mg, physician sample, 7 and 21 count boxes, Rx Only. NOT AN ORAL CONTRACEPTIVE!
c) Estrace tablets (estradiol tablets, USP) 2mg, physician sample, 7 and 21 count boxes, Rx Only. NOT AN ORAL CONTRACEPTIVE!
CODE a), b), and c) 64-GCA07.
RECALLING FIRM/MANUFACTURER Bristol-Myers Squibb Company, Princeton, N.J.
REASON Dissolution failure.
VOLUME OF PRODUCT IN COMMERCE 106,871 blisters.
DISTRIBUTION Nationwide.


PRODUCT Oxygen, USP, Compressed, cylinders, sizes-H, E, D, C, ML 6 and M6, Rx. 
CODE All Lots.
RECALLING FIRM/MANUFACTURER Classic Medical Inc., St. Clair Shores, MI.

REASON Good Manufacturing Practice Deviations (GMPs); including but not limited to, failure to perform purity analysis.
VOLUME OF PRODUCT IN COMMERCE Pending determination (estimate 50 cylinders).
DISTRIBUTION MI.

 

PRODUCT
a) NuLYTELY, Powder for Reconstitution, (PEG 33350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution),

Rx only, disposable jug.
b) NuLYTELY, Powder for Reconstitution, Cherry Flavor, (PEG 33350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution), Rx only, Disposable jug.
c) NuLYTELY, Powder for Reconstitution, Lemon-Lime (PEG 33350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution), Rx only, disposable jug. 
d) NuLYTELY, Powder for Reconstitution, Orange Flavor, (PEG 33350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution), Rx only, disposable jug.
CODE
a) Lot Number: N3E005 Exp. Date: 5/06;
b) Lot Number: C3G020 Exp. Date: 7/05;
c) Lot Number: L3F014 Exp Date: 6/05;
d) Lot Numbers: R3G011 Exp. Date: 7/05 and R3E009, Exp. Date: 5/05.
RECALLING FIRM/MANUFACTURER Braintree Laboratories, Inc., Braintree, MA.
REASON Product overfill: double one ingredient (PEG-3350).
VOLUME OF PRODUCT IN COMMERCE 69,744 bottles.
DISTRIBUTION Nationwide.


PRODUCT TRASYLOL Injection (aprotinin), 200mL vial, Rx only.
CODE Batch Number: 250076L Expiration Date: 2/2004.
RECALLING FIRM/MANUFACTURER Bayer Corporation, West Haven, CT.

REASON Particulates: Delayed formation of a precipitate (stability).
VOLUME OF PRODUCT IN COMMERCE 2,649 vials.
DISTRIBUTION Nationwide.


PRODUCT Levoxyl tablets, (Levothyroxine, Sodium Tablets, USP), 25mcg, 100 count bottles, Rx only.
CODE Lot No. 7478, expiration 11/03.
RECALLING FIRM/MANUFACTURER King Pharmaceuticals, Inc., Bristol, TN.
REASON Subpotency: Stability failure (18 month CRT-controlled room temperature).
VOLUME OF PRODUCT IN COMMERCE 24,872 units.
DISTRIBUTION Nationwide.


PRODUCT Sterile Diluent for Humulin L, Humulin U and Lente Iletin, Lilly, 10 ml. vial. Warning: Use ONLY with insulins listed on side panel. PROFESSIONAL PACKAGE NOT TO BE SOLD. 
CODE 7RE39M and 7RT38M.
RECALLING FIRM/MANUFACTURER Eli Lilly and Company, Indianapolis, IN.
REASON Particulates: vials exhibit white particulates/ white precipitate on vial wall which does not resuspend.
VOLUME OF PRODUCT IN COMMERCE 6,814 vials.
DISTRIBUTION Nationwide, Canada and Japan.


PRODUCT Mentax(r) cream (butenafine HCL), 1%, Topical Antifungal Cream 1%, 12.2 gram tubes, Physician Sample, Rx only, For topical Dermatologic Use Only.
CODE Lot RBER, Expiration date Jan-04.
RECALLING FIRM/MANUFACTURER Bertek Pharmaceuticals, Inc., Durham, NC.
REASON Stability failure, sodium benzoate (18 month test point).
VOLUME OF PRODUCT IN COMMERCE 506,736 units.
DISTRIBUTION Nationwide.


PRODUCT Metoclopramide Injection, USP, 10 mg (5 mg/mL), 2 mL single dose, Flip top glass vial, Preservative Free, Rx only, For I.V. or I.M. use. 
CODE
89-297-DK, 89-364-DK, 90-364-DK, 90-012-DK, 90-013-DK, 90-414-DK, 90-498-DK, 91-095-DK, 91-317-DK, 92-093-DK, 92-435-DK, 92-591-DK,

92-529-DK, 92-530-DK, 92-644-DK, 93-039-DK, 93-040-DK, 93-164-DK, 93-450-DK, 94-031-DK, 94-500-DK, 94-407-DK, 94-441-DK, 95-369-DK,

95-427-DK, 96-661-DK, 96-663-DK, 01-163-DK, 01-403-DK; 01-404-DK, 02-498-DK, 02-590-DK, 02-071-DK, 02-135-DK, 03-238-DK, 03-281-DK, 03-338-DK, 03-377-DK, 04-539-DK, 04-097-DK, 04-119-DK, 05-161-DK, 05-411-DK.
RECALLING FIRM/MANUFACTURER Abbott International, Abbott Park, IL.
REASON Discoloration: solution discolored due to known degradent.
VOLUME OF PRODUCT IN COMMERCE 158,500.
DISTRIBUTION Nationwide.


PRODUCT Indigo Carmine Injection, Indigotindisulfonate Sodium Injection USP, 0.8% Solution; 5 mL ampoules, 10 per carton; Rx only, For Intravenous or Intramuscular use.
CODE Lot number 61013, Expiration date 06/05.
RECALLING FIRM/MANUFACTURER Akorn, Inc., Buffalo Grove, IL, by letter on September 29, 2003. Firm initiated recall is ongoing.
REASON The lot was manufactured from active (drug) pharmaceutical ingredient which failed to meet assay specifications.
VOLUME OF PRODUCT IN COMMERCE 41,420 ampules.
DISTRIBUTION Nationwide.

 

WEEK ENDING NOVEMBER 22

 

FDA Alerts U.S. Residents to Recall of Glaxo Smith Kline "Diskus" Asthma Medicines Sold in Canada

As a precaution, the Food and Drug Administration (FDA) is alerting U.S. residents to the recent recall of certain GlaxoSmithKline “Diskus” medicines sold in Canada to treat asthma and chronic obstructive pulmonary disease (COPD). The three asthma products – Ventolin Diskus, Flovent Diskus, and Serevent Diskus -- were recalled in Canada November 12th, 2003, because the products’ drug delivery system may not function properly and may deliver too little of the drug – or none at all. Canadian patients are being advised to return the affected product to the pharmacy or physician’s office where it was obtained in order to get a replacement.

 

FDA emphasizes that FDA-approved Diskus products (Advair and Serevent) sold in the U.S. through legitimate marketing channels are not subject to this recall. But because some U.S. residents have obtained precription drugs from Canada and elsewhere through on-line or storefront operations, they may have received these potentially substandard and ineffective products.

 

The specific affected lots of the products recalled in Canada, and additional information from the product manufacturer, are available on the Canadian website of GlaxoSmithKline at http://www.gsk.ca/en/media_room/news/public_advisory_en.pdf

 

U.S. patients who may have obtained these affected medications from Canada who have questions or concerns about these products should discuss them with their physician, pharmacist, or health care provider. Consumers and Healthcare professionals have been asked to report any suspected adverse events associated with the use of these products directly to GSK or Health Canada using the following contact information:

 

GlaxoSmithKline Inc.
7333 Mississauga road N
Mississauga, Ontario
L5N 6L4
Telephone: 1-800-387-7374

 

Canadian Adverse Reacton Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201c2
Ottawa, Ontario K1A 1B9
Toll free phone: 1-866-234-2345
Toll free fax: 1-866-678-6789
cadrmp@hs-sc.gc.ca


PRODUCT Terramycin (oxytetracycline), 50 mg/mL, Intramuscular Solution, (contains 2% lidocaine) 10 mL vials, FOR INTRAMUSCULAR USE ONLY, Rx only.
CODE Lot 0141K01A, Exp. Date 10/1/05.
RECALLING FIRM/MANUFACTURER Pfizer Inc., New York, NY.
REASON Presence of Precipitate/cloudy appearance.
VOLUME OF PRODUCT IN COMMERCE 44,820 Vials.
DISTRIBUTION Nationwide.


PRODUCT
a) Zyprexa Tablets (Olanzapine), 10 mg, 60 tablet bottles, Rx only.
b) Zyprexa Tablets (Olanzapine), 15 mg, 60 tablet bottles, Rx only.
CODE

a) Lot No./Exp Date: 6AH19A (01/05), 7AA39A (03/05), and 7EA97A (04/05).
b) Lot No./Exp. Date: 6AH35A (01/05) and 6AG70A (11/04).
RECALLING FIRM/MANUFACTURER Walsh Southwest, LLC, San Antonio, TX.
REASON Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 547.
DISTRIBUTION Nationwide.


PRODUCT Mexiletine Hydrochloride Capsules, USP, 150 mg, 100 capsule bottles, Rx only.
CODE Lot 49101M02 (Sept 2004).
RECALLING FIRM/MANUFACTURER Watson Diagnostic, Inc, Corona, CA.
REASON Capsule Defects: Split or broken capsules.
VOLUME OF PRODUCT IN COMMERCE 3352.
DISTRIBUTION Nationwide.


PRODUCT Sterile Diluent for Humulin L, Humulin U and Lente Iletin, Lilly, 10 ml. vial. Warning: Use ONLY with insulins listed on side panel. PROFESSIONAL PACKAGE NOT TO BE SOLD.
CODE 7RE39M and 7RT38M.
RECALLING FIRM/MANUFACTURER Lilly, Eli & Co., Indianapolis, IN.
REASON Particulates: vials exhibit white particles/white precipitate on vial wall which does not resuspend.
VOLUME OF PRODUCT IN COMMERCE 6,814 vials.
DISTRIBUTION Nationwide, Canada and Japan.


PRODUCT
a) Entrobar Barium Sulfate Suspension, Rx Only, (50% w/v barium sulfate USP suspension), Net Contents: 500 ml,
b) Entrocel, Methylcellulose solution, (1.8% w/v hydroxpropyl methylcellulose solution...), For Professional Use Only, Net Contents: 500 ml.
c) Entrokit Enteroclysis Kit,(This kit contains both Entrobar and Entrocel product).
d) Entrokit Enteroclysis Kit with Catheter.
CODE
a) Lot 21265, exp 12/31/2005;
b) Lot 21009, Exp 10/31/2005; Lot 21112, Exp 11/30/2005; Lot 21140, Exp11/30/2005.
c) Lot 30179, exp 12/31/2003; Lot 30442, exp 03/31/2004;
d) Lot 30179, exp 12/31/2003; Lot 30422, exp 03/31/2004; Lot 30494, exp 03/31/2004.
RECALLING FIRM/MANUFACTURER Mallinckrodt Inc, Hazelwood, MO.
REASON Mislabeling: Entrobar labeled bottles may contain Entrocel (clear liquid) or Entrocel labeled bottles may contain Entrobar (milky-white liquid).
VOLUME OF PRODUCT IN COMMERCE 906 cases (12 units/case).
DISTRIBUTION Nationwide.


PRODUCT Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains: Lopinavir 133.3mg, Ritonavir 33.3mg, 180 capsule bottles, Rx only.
CODE Lot # 852072E25, EXP Date 06/04 Lot #852002E21, EXP Date 12/03 or 2/04.
RECALLING FIRM/MANUFACTURER Dialysist West, Inc., Tempe, AZ.
REASON Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE 143 units.
DISTRIBUTION Nationwide.


PRODUCT
a) SYNTEST H.S. (Half-Strength Tablets), EACH TABLET CONTAINS: Esterified Estrogens .625mg/Methyltestosterone 1.25mg, 100 Tablet bottles, Syntho, Rx only.
b) SYNTEST D.S. (Double-Strength Tablets), EACH TABLET CONTAINS: Esterified Estrogens 1.25 g/Methyltestosterone 2.5 mg, 100 Tablet bottles.

CODE
a) Lot Nos: S02D02 (exp. date 03/04), S02D03 (exp. date 03/04), S02K02 (exp. date 09/04), S02K03 (exp. date 09/04), S02K10 (exp. date 09/04);
b) Lot No. S02D01 (exp. date 03/04).
RECALLING FIRM/MANUFACTURER Syntho Pharmaceuticals, Inc., Farmingdale, NY.
REASON Subpotency: finished product and/or content uniformity testing.
VOLUME OF PRODUCT IN COMMERCE 59,693 bottles of 100 tablets in total.
DISTRIBUTION Nationwide.


PRODUCT Tarka Tablets (trandolapril/verapamil HCI ER), 4mg/240mg, 100 count bottles, Rx only.
CODE Lot 02TK441016, Exp Date 12/2004.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON Mislabeling: Extended expiration date-product incorrectly declares expiration date as 12/2004 rather than the correct date of 7/2004.
VOLUME OF PRODUCT IN COMMERCE 7,453 bottles.
DISTRIBUTION Nationwide and Puerto Rico.


PRODUCT Vicodin HP Tablets (hydromorphone bitartrate and acetaminophen tablets, USP), 10mg/660mg, 500 count bottles, Rx only.
CODE Lot 03VICH5004, Exp. Date June 2006.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD/GPRD, Abbott Park, IL.
REASON Mislabeling: Extended expiration date-product incorrectly declares expiration date as 6/2006 rather than the correct date of 6/2005.
VOLUME OF PRODUCT IN COMMERCE 108 bottles.
DISTRIBUTION Nationwide.


PRODUCT Actifed Cold & Allergy tablets (60 mg Pseudoephedrine HCl, 2.5 mg Triprolidine HCl), 12 count blister/carton.
CODE Lot No. Exp. Date 24112V 10/2005 15952V 6/2005.
RECALLING FIRM/MANUFACTURER Pfizer Inc., Morris Plains, NJ.
REASON Misbranding; some of the dosing information and/or ingredient listing information may be missing from the carton.
VOLUME OF PRODUCT IN COMMERCE 666,678.
DISTRIBUTION Nationwide.

 

WEEK ENDING NOVEMBER 29


PRODUCT TechneScan MAA, Technetium TC 99m Albumin Aggregated Injection and Kit (Lyophilized), Kit for the preparation of Technetium Tc 99m Albumin Aggregated, Rx Only, packaged in 5-vial kits or 30-vial kits.
CODE
Lot Number/Exp. Date:
0932024, Exp. 9/18/03;
0932026, Exp. 9/25/03;
0932027, Exp. 9/30/03;
0932028, Exp. 10/7/03;
0932030, Exp. 10/16/03;
0932031, Exp. 10/21/03;
0932032, Exp. 10/28/03;
0932033, Exp. 10/30/03;
0932034, Exp. 11/13/03;
0932035, Exp. 11/20/03;
0932036, Exp. 11/25/03,
0932037, Exp. 12/3/03;
0932038, Exp. 12/9/03;
0932039, Exp. 12/18/03;
0933001, Exp. 1/6/04;
0933005, Exp. 3/10/04;
0933006, Exp. 3/12/04;
0933007, Exp. 3/17/04;
0933008, Exp. 3/24/04;
0933009, Exp. 3/26/04;
0933010, Exp. 3/31/04;
0933013, Exp. 5/19/04;
0933014, Exp. 5/21/04;
0933015, Exp. 6/2/04;
0933016, Exp. 6/4/04;
0933018, Exp. 6/25/04;
0933019, Exp. 7/7/04.
RECALLING FIRM/MANUFACTURER Mallinckrodt, Inc., Maryland Heights, MO.
REASON Good Manufacturing Practice Deviations (GMPs) leading to product process variability within the manufacturing/sterility/validation process(es) which result in poor diagnostic scans (including but not limited to altered biodistribution/radiochemical impurity).
VOLUME OF PRODUCT IN COMMERCE 98,495 vials.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Comtrex SOFTGELS, Multi-Symptom, Deep Chest Cold, Pain Reliever/Fever Reducer, Expectorant, Cough Suppressant, Nasal Decongestant, 20 and 30 softgel capsule cartons. Active ingredients: Acetaminophen 250 mg., DexProduct Description (Label/Packaging) tromethorphan HBr 10 mg., Guaifenesin 100 mg., Pseudoephedrine HCl 30 mg.
CODE  20 Count Package, Lot Number/Expiration Date; 205564 Feb 04, 205601 Feb 04, 205602 Feb 04, 207549 Feb 04, 207550 May 04, 207551 June 04, 207598 June 04, 208557 June 04, 208558 June 04, 208559 June 04, 210503 June 04, 210504 June 04, 210505 June 04, 210506 July 05, 210507 July 05, 210508 July 05, 210509 July 05, 210510 July 05, 210532 July 05, 210533 Aug 04, 210593 July 04, 210594 Aug 04, 210595 Aug 04, 210622 July 04, 301507 May 04, 301508 Nov 04, 301556 Nov 04, 301557 Nov 04, 301558 Nov 04, 302578 Dec 04, 302579 Dec 04, 302580 Dec 04, 302592 Dec 04, 303567 Dec 04, 308511 May 05. 30 Count Package, Lot Number/Expiration Date; 306588 May 05, 308510 May 05, 308535 May 05, 309538 July 05, 309544 July 05. Display Number 1018: A3H1A May 05, A3H1C, May 05 Display Number 1081: A3H1A May 05.
RECALLING FIRM/MANUFACTURER Bristol-Myers Squibb Co., Hillside, NJ.
REASON Mis-Labeling: The dosing instructions incorrectly declare a maximum dose of 12 caps per 24 hour period (the maximum recommended dose should read 8 caps per 24 hour period).
VOLUME OF PRODUCT IN COMMERCE 67,706 packages.
DISTRIBUTION Nationwide and Trinidad.


PRODUCT Kaletra capsules (Lopinavir/Ritonavir), Each soft gelatin capsule contains: Lopinavir 133.3mg, Ritonavir 33.3mg, 180 capsule bottles, Rx only.
CODE Lot 852072E25 Lot 852002E21.
RECALLING FIRM/MANUFACTURER Jam Pharmaceutical, Orange, CA.
REASON Counterfeit: An unknown number of bottles bearing these lot numbers are counterfeit, in that they have been repackaged, relabeled and/or may contain different strengths or mixed strength tablets differing from their labeled contents and/or bear extended expiration dates, as the source of the repacked and/or relabeled bottles is unknown.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION Nationwide.


PRODUCT
a) DON'T BE BALD Hair Care Treatment, Medicated, "THE ORIGINAL FORMULAS", Net. Wt. 4 oz. Jars.
b) BBD 1854 Dandruff Shampoo, For Professional Use Only, Anti-Dandruff Conditioning Shampoo, 8 Fl. Oz. bottles (24 Liters).
c) Don't B Bald, Scalp Stimulate, Organic Formula, 4 Fl. Oz. (118 mL) Jars.
CODE
a) Batch numbers: 55, 64, and 69;
b) Batch number: 10269;
c) Batch numbers: 020800, 53.
RECALLING FIRM/MANUFACTURER Pride and Power, Inc., Houston, TX.
REASON Unapproved New Drug.
VOLUME OF PRODUCT IN COMMERCE 5,580 containers.
DISTRIBUTION Nationwide.


PRODUCT Morphine Sulfate (Immediate Release) Concentrated Oral Solution, 20 mg per mL, 30 mL bottle and dropper, Rx Only.
CODE Lot No: 47472.
RECALLING FIRM/MANUFACTURER Ethex Corporation, Bridgeton, MO.
REASON Mislabeling: Correctly labeled Oxydose Oral Concentrate Solution (20mg/1mL) bottles were mispackaged in holding cartons labeled as Morphine Sulfate.
VOLUME OF PRODUCT IN COMMERCE 12,250 bottles Oxydose.
DISTRIBUTION Nationwide.