JANUARY 2005

WEEK ENDING JANUARY 8

PRODUCT Enalaprail Maleate Tablets, USP, 5mg, 100 and 1000 count bottles, Rx only, NDC 0172-4196-80. 
CODE Lot # 109832A exp. Dec-04 Lot # 115188A exp. April -05 Lot # 117962A exp. May -05 Lot # 117962U exp. May Ð05.
RECALLING FIRM/MANUFACTURER Ivax Pharmaceuticals, Inc., Cidra, PR.
REASON Stability Failure.
VOLUME OF PRODUCT IN COMMERCE 26,424 bottles/units.
DISTRIBUTION Nationwide.

PRODUCT Glyburide Tablets, USP, 2.5 mg, 1000 count bottles, Rx only, ***** NDC 0093-8343-10. 1,714 bottles.
CODE Lot #132255A exp 3/06.
RECALLING FIRM/MANUFACTURER Teva Pharmaceuticals USA, North Wales, PA.
REASON Presence of foreign tablet (Hydrochlorothiazide 25 mg).
VOLUME OF PRODUCT IN COMMERCE 1,714 bottles..
DISTRIBUTION Nationwide.

PRODUCT Warfarin Sodium Tablets, USP, 7 1/2 mg, packaged in 100 count plastic bottles, Rx only, Pomona, NY 10970 *** NDC 0555-0834-02. 
CODE Lot 408343001, exp 9/05.
RECALLING FIRM/MANUFACTURER Barr Laboratories, Inc., Forrest, VA.
REASON Subpotent (12 month stability).
VOLUME OF PRODUCT IN COMMERCE 10,281 bottles (100 count).
DISTRIBUTION Nationwide.

PRODUCT
a) Dabso Gel Relieving Lotion, Net Wt. 4 oz. (120 gm) and 16 oz. jars. 
b) Fire In Ice Relieving Lotion, Net Wt. 4 oz. (120 gm) and 16 oz. jars. 
CODE
a) Lots 8050604A, 8AF06AEA, K072204B;
b) V020304D.
RECALLING FIRM/MANUFACTURER Unit Dose Packaging Inc, Chandler, AZ..
REASON Unapproved New Drug; contains Dimethyl Sulfoxide (DMSO).
VOLUME OF PRODUCT IN COMMERCE 24/ 16 oz and 65/ 4 oz containers.
DISTRIBUTION AZ, TX, and FL.

PRODUCT Pacerone (Amiodarone HCl) tablets, 300 mg, 100 tablets, Rx only,.Made in Israel, NDC 0245-0140-01. 
CODE 0415326468, expiration date 08/06 0415906531, expiration date 08/06 0415916532, expiration date 08/06.
RECALLING FIRM/MANUFACTURER Upsher Smith Laboratories, Inc., Maple Grove, MN.
REASON Mislabeling: Pacerone Unit dose carton is mislabeled in that UPC code scans as 100 mg strength instead of 300 mg strength which is the strength of the actual tablets. All human readable text of all labeling is accurate, including the unit dose card, carton and package insert.
VOLUME OF PRODUCT IN COMMERCE 1,740 total units distributed.
DISTRIBUTION Nationwide.

PRODUCT Potassium Chloride Extended-Release Tablets, USP, 20mEqK, 500 count bottles, Rx only, NDC 62037-720-05. 
CODE Lot # 720E022, Expiration Date Jan-2006.
RECALLING FIRM/MANUFACTURER Andrx Pharmaceuticals, Inc, Davie, FL.
REASON Tablet Weight.
VOLUME OF PRODUCT IN COMMERCE 2,154 bottles.
DISTRIBUTION Nationwide.

PRODUCT Doxepin Hydrochloride Oral Solution, USP (Concentrate), 10 mg/ml, 120 mL (4 fl.oz.) bottle, Rx only, ***** NDC 0093-9612-12. 
CODE Lot Number 21451 exp 2/2007.
RECALLING FIRM/MANUFACTURER Teva Pharmaceuticals USA. North Wales, PA.
REASON Failed pH specification (6 month stability).
VOLUME OF PRODUCT IN COMMERCE 8,618 bottles.
DISTRIBUTION Nationwide.

PRODUCT Rocaltrol Capsules (calcitriol) 0.5 mcg, bottle of 100 capsules, Rx only, *****NDC 004-0144-01. 
CODE Lot U2019 Exp. Date 7/2005.
RECALLING FIRM/MANUFACTURER Hoffmann La Roche Inc, Nutley, NJ.
REASON Presence of Foreign Tablet; bottled labeled as Rocaltrol 0.5mcg capsules contained Rocaltrol 0.5mcg capsules and one Rocaltrol 0.25mcg capsule.
VOLUME OF PRODUCT IN COMMERCE 6,601 bottles.
DISTRIBUTION Nationwide.

PRODUCT Premarin (conjugated estrogens) tablets, USP, 0.625 mg; Rx only, 1000 tablet bottles-NDC 0046-0867-91; 5000 tablet bottles- NDC 0046-0867-95. 
CODE A42766, EXP 9/05 - bottles of 1000; and A27633, EXP 3/05 - bottles of 5000.
RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond, VA.
REASON Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE 17,124 / 1,000 tab blt. and 2,880 / 5,000 tab. bottle.
DISTRIBUTION Nationwide.

PRODUCT Prempro (conjugated estrogens/medroxyprogesterone acetate tablets), 0.45 mg/1.5 mg/ carton of 3 EZ DIAL Dispensers of 28 tablets each, Rx only, NDC 0046-0937-09. 
CODE A50440, EXP 6/05.
RECALLING FIRM/MANUFACTURER Richmond Division of Wyeth, Richmond, VA.
REASON Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE 17,468 cartons x 3 dial packs distributed to wholesalers.
DISTRIBUTION Nationwide.

PRODUCT Visine Advanced Relief Eye Drops, (Dextran 70.0%, Polyethylene glycol 400.1%, Povidone 1%, Tetrahydrozoline HCl 0.05%), 1 fl oz (2). 
CODE In Case Lot Nos: 010438802, 010438803, 010438804 -- Unit Lot No. 0104388. In Case Lot No: 010440601 -- Unit Lot No. 0104406.
RECALLING FIRM/MANUFACTURER Pfizer Inc, Morris Plains, NJ.
REASON Defective bottle cap.
VOLUME OF PRODUCT IN COMMERCE 49128 bottles.
DISTRIBUTION Nationwide and Australia.

PRODUCT Calcitriol Injection, 2 mcg/mL, 1mL Single Dose Vial, 25 pack box, Rx only, For IV Use. .
CODE Lot 03B139.
RECALLING FIRM/MANUFACTURER Sicor Pharmaceuticals, Inc, Irvine, CA.
REASON Impurity failure (18 month stability).
VOLUME OF PRODUCT IN COMMERCE 92,300.
DISTRIBUTION Nationwide.

WEEK ENDING JANUARY 15

PRODUCT Peri-Colace Tablets. (8.6 mg Sennosides and 50 mg Docusate Sodium), 60 count bottles, Dist. by Purdue Products, Stamford, CT 08901, NDC 67618-106-60. 
CODE Lot 4C7985 Exp. Date March 31, 2006.
RECALLING FIRM/MANUFACTURER The Purdue Frederick Company, Stamford, CT.
REASON Presence of Foreign Tablet: One red tablet (Peri-Colase generic manufactured under the Time Capsules Lab label) was found in a 60 count bottle of Peri-Colase burgundy tablets.
VOLUME OF PRODUCT IN COMMERCE 25,196 bottles.
DISTRIBUTION Nationwide.

Alliant Pharmaceuticals Issues Voluntary Nationwide Recall of One Lot of Methylin® CT, 5mg

Alliant Pharmaceuticals, Inc. is voluntarily recalling one lot of Methylphenidate HCl Chewable Tablets, 5 mg strength, lot number #AMT50402A. After testing and evaluation, Alliant found that this lot of 5 mg strength might contain up to three times the active ingredient, and elected to recall the medication as it could pose serious health risk for some patients. Methylphenidate HCl Chewable Tablets (Methylin® CT) are a therapy for Attention Deficit Hyperactivity Disorder and Narcolepsy.

They will be asking pharmacists to notify patients who purchased the recalled product from their pharmacy. Distributors and pharmacies should check the lot numbers on the product label and promptly quarantine any product with the lot number #AMT50402A and expiration date of April 2006.

"We are committed to taking whatever steps are necessary to ensure the safety of all patients who use any one of our products," said Mark Pugh, President of Alliant Pharmaceuticals. "We are confident that this matter will be resolved quickly."

Of the 2,820 bottles from this lot, the company estimates fewer than 500 bottles of the affected product are in distribution.  Patients should call their pharmacists or physicians if they have questions about the recall. Health care providers or patients who have questions or wish to report adverse events can also contact Chris LaFreniere, Alliant Pharmaceuticals, at 770-817-4500.

Leiner Health Products Announces Recall of Multivitamins