MAY 2006

WEEK ENDING MAY 6

IVAX Pharmaceuticals Issues a Nationwide Recall of Goldline Brand Extra Strength Genapap and Extra Strength Genebs

IVAX Pharmaceuticals, Inc, Miami, FL, a distributor of Goldline labeled product is initiating a recall of Goldline™ brand Extra Strength Genapap 500mg (Acetaminophen) Caplets and Tablets and Extra Strength Genebs 500mg (Acetaminophen) Caplets and Tablets. The product lots identified below are being recalled due to a labeling error. Specifically, the product label should indicate that usage should not exceed 8 tablets or caplets in a 24 hour period. The erroneous label indicates not to exceed 12 tablets or caplets in a 24 hour period. In the event the maximum dosage of 8 tablets or caplets in a 24 hour period is exceeded, there may be an increased risk of acetaminophen toxicity to the liver, which may cause adverse health effects. 

Consumers who purchased Extra Strength Genapap 500mg Caplets and Tablets or Extra Strength Genebs 500mg Caplets or Tablets with the lot numbers listed below should cease usage and return the product to the location of purchase.

Wholesalers and Retailers should cease distribution and examine their inventory immediately. Return all lots indicated below to the IVAX Distribution Center at the following address;

IVAX Distribution Center
100 Precision Drive
Walton, KY 41094
Attn: RECALLED RETURNS

This recall includes the following product and lot numbers;

Product Name

NDC

Strength

Lot

Expiration

Packaging

Extra-Strength Genapap Caplets

0182-2152-01

500mg

5H018D

11/2008

100 count bottles

Extra-Strength Genapap Tablets

0182-1457-01

500mg

5L020B

11/2008

100 count bottles

Extra-Strength Genebs Tablets

0182-1453-10

500mg

5J006A

09/2008

1000 count bottles

Extra-Strength Genebs Tablets

0182-1453-10

500mg

5F001

09/2008

1000 count bottles

Extra-Strength Genebs Tablets

0182-1453-10

500mg

5H007

08/2007

1000 count bottles

Extra-Strength Genebs Tablets

0182-1453-10

500mg

5H007B

08/2008

1000 count bottles

Extra-Strength Genebs Tablets

0182-1453-10

500mg

5L014

11/2008

1000 count bottles

Extra-Strength Genebs Tablets

0182-1453-01

500mg

5L018

11/2008

100 count bottles

Extra-Strength Genebs Tablets

0182-1453-01

500mg

5L019

11/2008

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

5B003

02/2007

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

5F002

06/2007

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

5F004A

06/2007

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

5H003A

08/2008

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

5H005

08/2008

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

5H015

08/2008

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

5H016

08/2008

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

5H018B

11/2008

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

5M024

12/2008

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

5M030A

12/2008

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

6A014

01/2009

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-01

500mg

6B022B

02/2009

100 count bottles

Extra-Strength Genebs Caplets

0182-1832-10

500mg

5B016

02/2007

1000 count bottles

Extra-Strength Genebs Caplets

0182-1832-10

500mg

5F004

06/2007

1000 count bottles

Extra-Strength Genebs Caplets

0182-1832-10

500mg

5F010

06/2007

1000 count bottles

Extra-Strength Genebs Caplets

0182-1832-10

500mg

5F010C

06/2007

1000 count bottles

Extra-Strength Genebs Caplets

0182-1832-10

500mg

5H003

08/2007

1000 count bottles

Extra-Strength Genebs Caplets

0182-1832-10

500mg

5H018A

11/2008

1000 count bottles

Extra-Strength Genebs Caplets

0182-1832-10

500mg

5L009B

12/2008

1000 count bottles

Extra-Strength Genebs Caplets

0182-1832-10

500mg

5M008A

12/2008

1000 count bottles

Extra-Strength Genebs Caplets

0182-1832-10

500mg

5M030

12/2008

1000 count bottles

The tablets/caplets themselves meet product specification, however as stated above the product labeling is incorrect and should indicate not to exceed 8 tablets or caplets in a 24 hour period.

IVAX Pharmaceuticals method of distribution is through direct accounts, which includes wholesalers and retail pharmacies. These products are sold over the counter and have been distributed nationwide and in Puerto Rico.

IVAX is notifying the direct account customers/distributors and direct ship customers who have purchased these products and lots via first class mail recall notification.

Consumers with questions may contact 1-866-262-1243.

PRODUCT Prasco Laboratories, KL153 T-Tanna DM Suspension (Antihistamine/Decongestant Antitussive * Each 5ml (one teaspoonful) contains: Chlorpheniramine Tannate/ 4.5mg, Pseudoephedrine Tannate/ 75mg, Dextromethorphan Tannate/ 25mg * Cotton Candy Flavor * Rx Only * 16 fl.oz. (473 mL) *, NDC 66993-542-57, 
CODE Batches GB780, GB791, GB953, GB957
RECALLING FIRM/MANUFACTURER Kiel Laboratories, Gainesville, GA
REASON Superpotent: Out of specification results were detected.
VOLUME OF PRODUCT IN COMMERCE 6,376 bottles
DISTRIBUTION Nationwide

WEEK ENDING MAY 13

PRODUCT Myoview (Kit for the Preparation of Technetium Tc99m Tetrofosmin for Injection), 10 mL vial, carton of five vials, for Intravenous Injection, Each lyophilized vial contains 0.23 mg Tetrofosmin, 0.03 mg Stannous chloride dihydrate, 0.32 mg Disodium sulphosalicylate, 1.0 mg, Sodium D-gluconate, 1.8 mg Sodium hydrogen carbonate, Rx ONLY, 
CODE Lots: 1330; 1334. Expiration date or shelf life of Myoview is 10 months. When radioactive technetium is added to the Myoview vial, the shelf life is 12 hours.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Ge Healthcare, Princeton, NJ, 
Manufacturer: Amersham Health, United Kingdom. .
REASON Lack of Assurance of Sterility; firm used a non-sterile nitrogen gas filter during manufacturing of a sterile product.
VOLUME OF PRODUCT IN COMMERCE 22,055 kits
DISTRIBUTION Canada, Netherlands, Belgium, Spain, Europe, and Japan, and Nationwide

PRODUCT Phenylhistine DH, (each 5 mL contains: Codeine Phosphate 10mg, Pseudoephedrine Hydrochloride 30mg, Chlorpheniramine Maleate 2mg, Alcohol 5%), 4 fl oz., Rx only, NDC # 0603-1520-54, 
CODE Lot numbers: L016J04A (exp 09/06), L023L04A (exp 11/06), L068M04A (exp 12/06), L005D05A (exp 12/06), L017K05B (exp 10/07), L051A06A (exp 07/07)
RECALLING FIRM/MANUFACTURER Vintage Pharmaceuticals, Huntsville, AL
REASON Subpotent: OOS (below specification) at 18 months for Codeine Phosphate.
VOLUME OF PRODUCT IN COMMERCE 101,462 units
DISTRIBUTION Nationwide and PR

PRODUCT Zoloft (sertraline hydrochloride), Oral Concentrate, 20 mg/mL, 60 mL bottle, Rx only, NDC 0049-4940-23, 
CODE Lot 0105475, Exp. Date 01DEC2008
RECALLING FIRM/MANUFACTURER
Recalling Firm: Pfizer Inc., New York, NY,
Manufacturer: Pfizer Inc., Parsippany, NJ, 
REASON One lot of Zoloft Oral Concentrate was found to contain trace amounts of isopropyl alcohol.
VOLUME OF PRODUCT IN COMMERCE 9,237 bottles
DISTRIBUTION Nationwide

PRODUCT
a) Analpram HC Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%) Net Wt.
1 oz metal tube, Rx only, NDC 0496-0778-04, 
b) Analpram HC Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%)
Professional sample, Net wt. 3 gram metal tube, Rx only, NDC 0496-0778-33,
c) Analpram HC Cream 2.5% (hydrocortisone acetate 2.5% and pramoxine HCl 1%) Net
Wt. 1 oz metal tube, Rx only, NDC 0496-0800-04. 
d) Pramosone Cream 1% (hydrocortisone acetate 1% and pramoxine HCl 1%), Net wt.
1 ounce metal tube, Rx only, NDC 0496-0716-04. 
e) Pramosone Cream 2.5% (hydrocortisone acetate 2.5% and pramoxine HCl 1%), Net
wt. 1 ounce and 2 ounce tubes, Rx only, NDC 0496-0717-04 and 0496-0717-03.
CODE
a) Lots 04135A (exp. 08/07), 04136A (exp. 08/07), 04186A (exp. 11/07), 04189A (exp. 11/07), 04190A (exp. 11/07), 04191A (exp. 11/07), 04201A (exp. 12/07) and 04202A (exp. 12/07);
b) Lot 04187A (exp. 11/07);
c) Lots 04122A (exp. 07/06), 04123A (exp. 07/06), 04124A (exp. 07/06) and 04138A (exp. 08/06);
d) Lot 04045A (exp. 03/07);
e) Lots 04067A (exp. 05/06), 04068A (exp. 05/06), 04069A (exp. 05/06) and
04070A (exp. 05/06), and 04121A (exp. 07/06)
RECALLING FIRM/MANUFACTURER Ferndale Laboratories, Inc., Ferndale, MI
REASON Superpotent: The metal tubes may have pinhole defects, which would result in a superpotent product.
VOLUME OF PRODUCT IN COMMERCE 196,742 tubes
DISTRIBUTION Nationwide

Nutritech Corp. Issues Nationwide Allergy Alert on Undeclared Milk in "All One: Calcium Complex"

Nutritech Corp. of Santa Barbara, CA is recalling its 8.5 ounce jug of "ALL ONE Calcium Complex" with expiration dates of 03/06 through 06/07 food supplement because it may contain undeclared milk products. 

"ALL ONE Calcium Complex" was distributed nationwide to distributors, in retail stores and through mail order.

The product comes in an 8.5 ounce, white plastic jug with a green label marked "ALL ONE Calcium Complex."

Stores that carry "ALL ONE Calcium Complex" should remove the product from sale and return it to their distributor. Consumers who have purchased ALL ONE Calcium complex who have an allergy to milk are urged to return it to the place of purchase for a full refund. 

Consumers with questions may contact the company at 1-800-235-5727.

WEEK ENDING MAY 20

PRODUCT Amoclan (Amoxicillin and Clavulanate Potassium Powder for Oral Suspension USP), 200mg/28.5mg per 5mL), supplied in 50mL (NDC 0143-9981-50) , 75mL (0143-9981-75), and 100mL (0143-9981-01 ) bottles, Rx only, 
CODE Lot - Exp. Date: AG007A, 03/2007; AG010A, 06/2007; AG011A, 06/2007; AG006B, 03/2007; AG008B, 03/2007; AG009B, 06/2007; AG011B, 06/2007; AG007C, 03/2007; AG008C, 03/2007; AG009C, 06/2007; AG010C, 06/2007; AG011C, 06/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: West-ward Pharmaceuticals Corp., Eatontown, NJ, .
Manufacturer: Hikma Pharmaceuticals, Amman, Jordan. .
REASON Discoloration (clavulanic acid -- 9 month stability)
VOLUME OF PRODUCT IN COMMERCE 16,518 bottles
DISTRIBUTION Nationwide

WEEK ENDING MAY 27

PRODUCT Theophylline Extended-Release Tablets, 450 mg, Rx only, 100 tablets per bottle, CODE Lot 5185001SB, Exp. 2/2008
RECALLING FIRM/MANUFACTURER Pliva, Inc, East Hanover, NJ
REASON Subpotent: OOS result obtained for the 6 month stability station during the L3 drug release analysis at the 12th hour time point.
VOLUME OF PRODUCT IN COMMERCE 3,114 bottles
DISTRIBUTION Nationwide

PRODUCT Trimethoprim Tablets, USP, 100 mg, 100 count bottles,
CODE Lot # 139935A, Exp. 11/2007
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teva Pharmaceuticals, USA, Sellersville, PA, 
Manufacturer: Novapharm Limited, Toronto, Canada,
REASON Oversized Tablets; may contain a superpotent dose.
VOLUME OF PRODUCT IN COMMERCE 13,596 bottles
DISTRIBUTION Nationwide

PRODUCT Sodium Sulfate Decahydrate USP, BP, PhEur, in 500 gram plastic bottles and 12 kg poly pail, Use in manufacturing, processing, and repacking
CODE Lot TA793642, (A), (B), (D)
RECALLING FIRM/MANUFACTURER
Recalling Firm: EMD Chemicals, Inc, Gibbstown, NJ,
Manufacturer: Merck KgaA, Darmstadt, Germany, 
REASON Failed USP Loss on Drying Test.
VOLUME OF PRODUCT IN COMMERCE 22 units
DISTRIBUTION MA, KY, and Canada