SEPTEMBER 2006

SEPTEMBER 2006

WEEK ENDING SEPTEMBER 9

PRODUCT Carbidopa and Levodopa tablets, 25 mg/100 mg, Rx Only, 30 unit dose tablets per box, NDC 61392-180-30,
CODE Lot #C42986A30, Exp. 05/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Heartland Repack Services LLC, Toledo OH,
Manufacturer: Actavis Elizabeth LLC, Elizabeth NJ.
REASON Label on the end panel of the outer carton incorrectly identifies the strength of Levodopa as 250 mg; product contains only 100 mg Levodopa. Strength printed on unit dose strip is correct.
VOLUME OF PRODUCT IN COMMERCE 1,389/30 unit dose tablet boxes
DISTRIBUTION WV, MD, and PA

PRODUCT Baclofen 10mg Tablets USP, Rx only, NDC 0172-4096-60,
CODE Lot # 140373A Exp. 08/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami FL,
Manufacturer: Ivax Pharmaceuticals, Inc, Cidra, PR.
REASON Impurities/Degradation Products: Unidentified extraneous peaks was noted at chromatographic analysis. Chromatographic analysis of extraneou peak was determined to be insufficient
VOLUME OF PRODUCT IN COMMERCE 37,440 bottles of 100 count
DISTRIBUTION Nationwide

PRODUCT
a) Cilostazol 100mg Tablets, 500 count unit dose, Rx only, NDC 0172-5841-70
b) Cilostazol 100 mg tablets 100 count unit dose, Rx only, NDC 0172-5841-10,
CODE
a) Lot 133086VG Exp 12/2006;
b) Lot # 133086VUF Exp 12/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: IVAX Pharmaceuticals, Miami FL,
Manufacturer: Ivax Pharmaceuticals, Inc, Cidra, PR.
REASON Impurities/Degradation Products: For products and/or lots, unidentified extraneous peaks were noted at chromatographic analysis. Chromatography analysis of extraneous peaks was determined to be insufficient.
VOLUME OF PRODUCT IN COMMERCE
a) 1,191 bottles;
b) 2,083 unit dose boxes
DISTRIBUTION Nationwide

PRODUCT
a) Thyro-Tab 0.050 mg tablet, packaged in 150,000-tablet bulk drums intended for
repackaging, RX, no NDC number,
b) Levothroid (levothyroxine sodium tablets, USP), 50 mcg, packaged in
100- and 1,000-count bottles, NDC #0456-1321-01 (100-ct) and
#0456-1321-00 (l,000-ct.), RX,
CODE
a) Lots HB23405, HC23405, HD23405, exp. for all lots September 2006;
b) Lots 090532, 090536, 090537, exp. for all lots September 2006
RECALLING FIRM/MANUFACTURER Lloyd Inc of Iowa, Shenandoah IA,
REASON Subpotent: One lot of product failed at the 9-month stability test interval.
VOLUME OF PRODUCT IN COMMERCE 5,828,667 bulk tablets; 38,407/100-tab. bottles and 1,800/1,000-tab. bottles
DISTRIBUTION
a) OH; b) Nationwide

PRODUCT Technetium Tc99m TSC, Kit for the Preparation of Technetium Tc99m Sulfur Colloid Injection,
CODE Lot Numbers: 6436; 6439; 6443; 6447
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Princeton NJ,
Manufacturer: CIS-US, Inc., Bedford MA.
REASON Stability does not support expiration date.
VOLUME OF PRODUCT IN COMMERCE 30,775 vials
DISTRIBUTION Nationwide and Internationally

PRODUCT Adult Low Strength Aspirin 81 mg, Enteric Safety Coated, OTC, under the following brand names and bottle sizes: Meijer brand 300 tablet bottles Dist. by Meijer Distribution, Inc, Grand Rapids, MI, NDC 41250-535-87; Member’s Mark brand 500 tablet bottles Dist. by SWC, Bentonville, AR; Equaline brand 300 tablet bottles Dist. by Albertsons Inc, Boise, ID, NDC 41163-535-87; HyVee brand 120 tablet bottles Dist. by Hy-Vee, Inc., West Des Moines, IA,
CODE Lots 4DE0756, 4DE0703 and 4EE0854; EXP. 01/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Perrigo Company, Allegan MI,
Manufacturer: Time Caps Labs, Farmingdale NY.
REASON Dissolution failure: Coating defects may result in the product not being delayed release as labeled.
VOLUME OF PRODUCT IN COMMERCE 38,784 bottles
DISTRIBUTION Nationwide

WEEK ENDING SEPTEMBER 16

PRODUCT Levoxyl (Levothyroxine sodium tablets, USP) 125 mcg, 100 count bottles, Rx only,
CODE Lot number 20784
RECALLING FIRM/MANUFACTURER
Recalling Firm: Rx PAK, MemphisTN,
Manufacturer: King Pharmaceuticals, Inc. (St. Petersburg Facility), Saint Petersburg, FL. REASON Potential sub-potency at the 15 month stability interval
VOLUME OF PRODUCT IN COMMERCE 2020 units
DISTRIBUTION Nationwide

PRODUCT Levoxyl (Levothyroxine sodium tablets, USP) 112mcg, Rx, Item #537845. The medication is repackaged and distributed in 100 tablet bottles,
CODE Lot number: 053668, Expiration: 09/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Amerisource Health Services, Columbus, OH,
Manufacturer: King Pharmaceuticals, Inc., (St Petersburg Facility), Saint Petersburg, FL. REASON Subpotent: The tablets have the potential to fail below the manufacturer’s potency specifications before their labeled expiration date.
VOLUME OF PRODUCT IN COMMERCE 1,007 bottles
DISTRIBUTION Nationwide

PRODUCT Cocaine Hydrochloride Topical Solution 4% packed in 4mL glass bottles, CODE Lot Numbers: 656429A - Expiration Date: Apr 07; and Lot #656795B, Expiration Date: May 07
RECALLING FIRM/MANUFACTURER Boehringer Ingelheim Corporation, Columbus, OH,
REASON Mislabeling: The folding carton for the Cocaine Hydrochloride 4% topical solution lists the incorrect milligram strength for the product.
VOLUME OF PRODUCT IN COMMERCE 44,452 units
DISTRIBUTION Nationwide

PRODUCT Baraclude (Entecavir) Oral Solution, 0.05 mg/mL, 210 mL, Rx only, NDC 0003-1614-12,
CODE Lots: 4M4305B, exp. 12/06; 4M4306B, exp. 12/06
RECALLING FIRM/MANUFACTURER Bristol-Myers Squibb Company, Mead Johnson Park, Evansville, IN,
REASON Lots do not meet specification for total impurities throughout indicated shelf life
VOLUME OF PRODUCT IN COMMERCE 439 bottles
DISTRIBUTION Nationwide

PRODUCT Rosaderm(tm) Cleanser * (Sodium Sulfacetamide 10% and Sulfur 5%) * Rx only: For dermatologic use only * Net Wt. 6 oz (170g),
CODE Various
RECALLING FIRM/MANUFACTURER Harmony Labs, Inc, Landis,NC,
REASON Subpotent: Product fails to support 24 months expiration date.
VOLUME OF PRODUCT IN COMMERCE 120,271 units
DISTRIBUTION GA

WEEK ENDING SEPTEMBER 23

Nasutra, LLC Issues a Nationwide Recall of Nasutra, a Product Marketed as a Dietary Supplement To Support Male Sexual Performance

Nasutra, LLC announced that it is conducting a nationwide recall of all the Company’s dietary supplement product that is sold under the brand name Nasutra. Finished product from several lots of Nasutra was tested and preliminarily found to contain an analogue of an ingredient in an FDA-approved drug. Analytical tests of Nasutra samples from two lots concluded that the products contained acetildenafil. Acetildenafil is an analogue of sildenafil. Sildenafil is the active pharmaceutical ingredient in Viagra, an FDA-approved drug that is used to treat erectile dysfunction (ED). Acetildenafil is close in structure to sildenafil and is expected to possess a similar pharmacological and adverse event profile. This poses a threat to consumers because acetildenafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Additionally, acetildenafil, like sildenafil, may cause side effects, such as headaches and flushing.

Customers who have this product in their possession should stop using it immediately and contact their physician if they have experienced any problems that may be related to taking this product.

The Company is advising consumers to return any unused Nasutra, for a refund of the full purchase price, to the retail location from which it was purchased or to the Company directly if it was purchased from the Company as a part of its Direct Response Program.

Consumers can call 1-800-568-3374 to receive instructions for returning the product. Additional information is provided on the Company’s website at www.nasutra.com/recall.

PRODUCT Amantadine Hydrochloride Capsules, USP, 100 mg; an Rx oral antiviral and antiparkinson agent; single soft gelatin capsule unit dose blister packs, 10 sheets of 10 unit dose capsules per carton; NDC # 51079-481-20,
CODE Lot: 6B943, Expiration Date 08/07
RECALLING FIRM/MANUFACTURER UDL Laboratories, Inc., Rockford, IL
REASON Failed USP Content Uniformity Requirements.
VOLUME OF PRODUCT IN COMMERCE 3,587 unit cartons
DISTRIBUTION Nationwide including PR

PRODUCT
a) Uritact-EC Tablets, each enteric coated tablet contains Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg; 90 tablets, Rx Only, NDC 60258-517-09,
b) Prosed/DS Tablets, each tablet contains Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg; Rx Only. 100 tablet bottles, NDC 0076-0108-03; 4 tablet Physician
Samples, NDC 0076-0108-02,
c) Prosed EC tablets, each enteric coated tablet contains Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg; Rx Only, 90 tablet bottles, NDC 15456-0909-90,
d) Prosed EC tablets, each enteric coated tablet contains Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg; Rx Only, pouch containing 2 tablets, NDC 0076-0909-02,
CODE
a) Lot 053104 (exp. 7/08);
b) Lots: 043151, 043617, 044513;
c) Lots: 042253, 043616, 044512, 053615;
d) Lots: 042253, 043616, 044512, 053615
RECALLING FIRM/MANUFACTURER Contract Pharmacal Corporation, Hauppauge NY,
REASON No testing was performed for hyoscyamine sulfate and atropine sulfate ingredients in these products to determine satisfactory conformance to specifications and to verify stability of these products over labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE Uritact-EC: 5,874 bottles; Prosed/DS: 9,598 bottles; Prosed-EC: 27,709 bottles & 20,016 displays (12 x 2 tabs)
DISTRIBUTION Nationwide

PRODUCT PREMARIN® (conjugated estrogens tablets, USP) 0.9 mg, bottles of 100 tablets, Rx only, NDC 0046-0864-81 (old NDC # - old formulation),
CODE Lot: B17989, Exp. Date 6/2007
RECALLING FIRM/MANUFACTURER Wyeth Pharmaceuticals, Inc., Rouses Point, NY
REASON Dissolution Failure: Failed USP dissolution test requirement.
VOLUME OF PRODUCT IN COMMERCE 97,301 units
DISTRIBUTION Nationwide

WEEK ENDING SEPTEMBER 30

PRODUCT
a) Prosed EC tablets, each enteric coated tablet contains Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg; Rx Only, 90 tablet bottles, NDC 15456-0909-90,
b) Prosed EC tablets, each enteric coated tablet contains Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg; Rx Only, Physician sample containing 12/ 2-tablet packets, NDC 0076-0909-02,
c) Prosed/DS Tablets, each tablet contains Methenamine 81.6 mg, Phenyl Salicylate 36.2 mg, Methylene Blue 10.8 mg, Benzoic Acid 9.0 mg, Atropine Sulfate 0.06 mg, Hyoscyamine Sulfate 0.06 mg; Rx Only, 100 tablet bottles, NDC 0076-0108-03,
CODE
a) Lots: 042253 exp. 7/31/06, 044512 exp. 1/31/07, 053615 exp. 3/31/08;
b) Lots: 043616 exp. 11/31/06, 044512 exp. 1/31/07;
c) Lot s: 043151 exp. 8/31/06, 043617 exp. 11/30/06, 044513 exp. 1/31/07
RECALLING FIRM/MANUFACTURER
Recalling Firm: Esprit Pharma, Inc., East Brunswick, NJ
Manufacturer: Contract Pharmacal Corporation, Hauppauge, NY.
REASON No testing was performed for hyoscyamine sulfate and atropine sulfate ingredients in these products to determine satisfactory conformance to specifications and to verify stability of these products over labeled shelf life.
VOLUME OF PRODUCT IN COMMERCE 44,124 bottles and physician samples
DISTRIBUTION Nationwide