Non-Diabetes Related Medication Recalls

[We Hope]

http://www.fiercepharma.com/story/fda-bars-teva-vet-drugs-compliance-issues/2009-08-03

FDA bars Teva vet drugs on compliance issues

FiercePharma.com August 3, 2009

"More manufacturing problems, more FDA action. This time it's Teva Pharmaceuticals in the stocks--but veterinary meds, not people drugs. The FDA announced late Friday that it had filed a consent decree requiring Teva Animal Health to get the agency's once-over and okay before making or selling any more animal treatments. The decree also prohibits the company and three executives from making and distributing "adulterated" veterinary drugs.

"FDA said its inspectors had found "significant" violations of good manufacturing practice at the company's facilities in St. Joseph, Mo. "The FDA will not tolerate the manufacture and distribution of adulterated animal drugs," Michael Chappell, the FDA's acting associate commissioner for regulatory affairs, said in a statement. "Veterinarians and pet owners can be assured that the FDA will investigate and take regulatory actions against companies that produce animal drugs under conditions and controls that are inadequate.""

Those of you who are using meds other than insulin may want to check if you have any Teva-produced products at home.

http://www.tevaanimalhealth.com/Products/ProductSearch.aspx?searchTerm=&searchType=

The link is to a searchable database of their products.

Kathy

[We Hope]

http://news.vin.com/VINNews.aspx?articleId=13680

VIN News August 20, 2009

"Virbac Animal Health has recalled Iverhart Plus flavored chewable tablets for dogs after routine stability tests showed that samples from two lots did not contain sufficient amounts of ivermectin to give dogs weighing 85 pounds or more six months of parasite protection.

"The company, which sent out a letter to distributors last Friday, reports that lots 090093 and 090095 of the heartworm preventative, sold between March 20 and April 5, are affected.

"A third lot, 090073, initially was named in the recall, but subsequent tests revealed the related product was not subpotent.

"While Virbac did not share the company’s letter with the VIN News Service, sales representative Tara Youngblood explains that veterinarians are being asked to contact their distributors to see if they’ve purchased product from the recalled lots.

“"It’s not going to harm the dog. There wasn’t enough (ivermectin) to keep the dog (heartworm) free for the whole six months,” she explains.

"The VIN News Service (VNS) contacted Midwest Veterinary Supply and Webster Veterinary Supply to get more information from the recall letter, and representatives at both companies refused to relay any details about it.

"But Vedco Inc., a generics distributor that feeds more than a half-dozen smaller veterinary supply companies, shared Virbac's recall letter with VNS. The document marked "urgent" asks that distributors track down what veterinary practices might be carrying recalled product and return the inventory to Vedco.

"Replacement product or credit will be issued after the return of a completed and signed recall response form and the receipt of the returned product, Virbac's letter to distributors states.

"Butler Animal Health officials say they did not receive a recall letter from Virbac. “It’s very possible that we didn’t purchase from the lot numbers involved,” a representative contends.

"Virbac’s Youngblood explains that the company is sending inquiries to veterinary practices, via their distributors, asking that doctors name the owners of all dogs that were administered Iverhart Plus from the recalled lots.

"The company is picking up the tab for additional heartworm tests for dogs weighing 75 pounds or more. Those tests should be conducted within six months of a dog’s last Iverhart Plus dose, Youngblood says.

"It was not immediately known whether Virbac plans to pay for any adulticide treatments of dogs who were given subpotent doses if they test positive for heartworms."

[We Hope]

http://news.vin.com/VINNews.aspx?articleId=13680

VIN News August 20, 2009

"Virbac Animal Health has recalled Iverhart Plus flavored chewable tablets for dogs after routine stability tests showed that samples from two lots did not contain sufficient amounts of ivermectin to give dogs weighing 85 pounds or more six months of parasite protection.

"The company, which sent out a letter to distributors last Friday, reports that lots 090093 and 090095 of the heartworm preventative, sold between March 20 and April 5, are affected.

"A third lot, 090073, initially was named in the recall, but subsequent tests revealed the related product was not subpotent.

"While Virbac did not share the company’s letter with the VIN News Service, sales representative Tara Youngblood explains that veterinarians are being asked to contact their distributors to see if they’ve purchased product from the recalled lots.

“"It’s not going to harm the dog. There wasn’t enough (ivermectin) to keep the dog (heartworm) free for the whole six months,” she explains.

"The VIN News Service (VNS) contacted Midwest Veterinary Supply and Webster Veterinary Supply to get more information from the recall letter, and representatives at both companies refused to relay any details about it.

"But Vedco Inc., a generics distributor that feeds more than a half-dozen smaller veterinary supply companies, shared Virbac's recall letter with VNS. The document marked "urgent" asks that distributors track down what veterinary practices might be carrying recalled product and return the inventory to Vedco.

"Replacement product or credit will be issued after the return of a completed and signed recall response form and the receipt of the returned product, Virbac's letter to distributors states.

"Butler Animal Health officials say they did not receive a recall letter from Virbac. “It’s very possible that we didn’t purchase from the lot numbers involved,” a representative contends.

"Virbac’s Youngblood explains that the company is sending inquiries to veterinary practices, via their distributors, asking that doctors name the owners of all dogs that were administered Iverhart Plus from the recalled lots.

"The company is picking up the tab for additional heartworm tests for dogs weighing 75 pounds or more. Those tests should be conducted within six months of a dog’s last Iverhart Plus dose, Youngblood says.

"It was not immediately known whether Virbac plans to pay for any adulticide treatments of dogs who were given subpotent doses if they test positive for heartworms."

[We Hope]

http://www.fda.gov/Safety/Recalls/EnforcementReports/ucm181754.htm

FDA Enforcement Report, September 9, 2009

RECALLS AND FIELD CORRECTIONS: VETERINARY - CLASS II

PRODUCT

1) Levothyroxine Sodium Tablets 0.2 mg, packaged in 180-, and 1,000-tablet bottles, RX, under the following labels: (1) AmTech Group Inc. Levothyroxine Sodium Tablets 0.2 mg. and (2) Phoenix Pharmaceutical, Inc. Thyrozine 0.2 mg, Recall # V-260-2009;

2) Levothyroxine Sodium Tablets 0.5 mg, packaged in 180-, and 1,000-tablet bottles, RX, under the following labels: (1) AmTech Group Inc. Levothyroxine Sodium Tablets 0.5 mg. and (2) Phoenix Pharmaceutical, Inc. Thyrozine 0.5 mg, Recall # V-261-2009;

3) Levothyroxine Sodium Tablets 0.8 mg, packaged in 180-, and 1,000-tablet bottles, RX, under the following labels: (1) AmTech Group Inc. Levothyroxine Sodium Tablets 0.8 mg. and (2) Phoenix Pharmaceutical, Inc. Thyrozine 0.8 mg, Recall # V-262-2009;

4) Phenylbutazone Tablets, 1 g., packaged in 100-tablet bottles, RX, under the following labels: (1) A & G Pharmaceuticals Phenylbutazone Tablets, USP; (2) Pro Labs Pro-Bute Tablets; (3) Butler ButaTabs E; (4) AmTech Group Inc. Phenylbutazone Tablets, USP; (5) Phoenix Pharmaceutical Inc. Phenylbute Tablets; (6) VetTek Phenylbutazone Tablets; (7) VEDCO Bute Tabs; and (8) RXV Phenylbutazone Tablets, USP, Recall # V-263-2009;

5) Phenylbutazone Tablets, 100 mg, packaged in 1,000-tab. bottles, RX, under the following labels: (1) Butler ButaTabs D; and (2) AmTech Group, Inc. Phenylbutazone Tablets, USP, Recall # V-264-2009;

6) Praziquantel Tablets, 34 mg, RX, packaged under the following labels: (1) Trade Winds Tape Worm Tabs, packaged in 5-tab. bottles; (2) Farnam D-Worm Praziquantel Tablets, packaged in 5- and 10-tab. bottles; (3) Phoenix Pharmaceutical Inc. CestaTabs, packaged in 50- and 150-tab. bottles; (4) VEDCO Cestoved Tablets, packaged in 50- and 150-tab. bottles; (5) Butler Prazitabs D, packaged in 50- and 150-tab. bottles; and (6) AmTech Group Inc. Praziquantel Tablets, packaged in 50- and 150-tab. bottles, Recall # V-265-2009;

7) Clindamycin Hydrochloride Capsules, 25 mg, packaged in 600-cap. bottles, RX, under the following labels: (1) Butler Clincaps 25; (2) VEDCO ClindaCure; (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules; and (4) AmTech Group, Inc. Clindamycin Hydrochloride Capsules, Recall # V-266-2009;

8) Clindamycin Hydrochloride Capsules, 75 mg, packaged in 200-cap. bottles, RX, under the following labels: (1) Butler Clincaps 75; (2) VEDCO ClindaCure; (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules; and (4) AmTech Group, Inc. Clindamycin Hydrochloride Capsules, Recall # V-267-2009;

9) Clindamycin Hydrochloride Capsules, 150 mg, packaged in 100-cap. bo9ttles, RX, under the following labels: (1) Butler Clincaps 150; (2) VEDCO ClindaCure; (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules; and (4) AmTech Group, Inc. Clindamycin Hydrochloride Capsules, Recall # V-268-2009;

10) Clindamycin Hydrochloride Capsules, 300 mg, packaged in 100-cap. bottles, RX, under the following labels: (1) Butler Clincaps 300; (2) VEDCO ClindaCure; and (3) Phoenix Pharmaceutical, Inc. Clindamycin Hydrochloride Capsules, Recall # V-269-2009

CODE

1) 180 ct. – Lot numbers: 8020127 and 8050365; 1,000-ct. - Lots 7071016, 7071017, 7101394, 7101395, 8010055, 8020128, 8030254, 8070482, 8070483, 8080551, and 8080552;

2) 180-ct. – Lot numbers: 8050366 and7081165; 1,000-ct. - Lots 7101396, 7101397, 7111484, 7111485, 8020129, 8020130, 8030211, 8030212, 8070484, and 8070485;

3) 180-ct. – Lot numbers: 7050762, 7111488, 8040300, and 8080553; 1,000-ct. - Lots 7040661, 7040662, 7040663, 7101398, 7101399, 7101400, 7101401, 7111486, 7111487, 8010042, 8010043, 8020131, 8020132, 8020133, 8030221, 8030222, 8030223, 8040300, 8040301, 8040302, 8040303, 8070486, and 8070487;

4) Lot numbers: 7081167, 7081168, 7101409, 7101410, 7101446, 7111480, 7111481, 7111482, 7121563, 7121564, 8020166, 8030225, 8030272, 8030273, 8040304, 8040305, 8050367, 8070477, 8070478, 8080554, 8080555, 8090611, 8090612, 8090613, 8100686, 8100687, 8110786, and 9010019;

5) Lot numbers: 7060905, 7111483, 8060462, and 8100756;

6) Lot numbers: 7050776 (150-ct.), 7050781 (10- and 150-ct.), 7060920 (5- and 10-ct.), 7081161 (50-ct.), 7101411 (5- and 10-ct.), 7101441 (150-ct.), 7111498 (5-ct.), 7121598 (50-ct.), 7121599 (150-ct.), 8020155 (5- and 10-ct.), 8020156 (5- and 10-ct.), 8030224 (150-ct.), 8060414 (10-ct.), 8060415 (5- and 10-ct.), 8060445 (5-ct.), 8060446 (50-ct.), 8080550 (5- and 10-ct.), 8090609 (50-ct.), 8090610 (150-ct.), 8100685 (10- and 150-ct.), 8110785 (5- and 10-ct.), 9010018 (50-ct.), and 9020094 (150-ct.);

7) Lot numbers: 7050763, 7050764, 7071012, 7081157, 7101389, 7111489, 8010001, 8010002, 8020165, 8030219, 8040338, 8070479, 8070480, 8080556, 8080557, 9010020, and 9010068;

8) Lot numbers: 7050761, 7071013, 7081160, 8010044, 8030220, 8040306, 8070481, 8120869, 9010021, and 9010022;

9) Lot numbers: 7101390, 7101440, and 8090614;

10) Lot numbers: 7071014 and 8080558

RECALLING FIRM/MANUFACTURER

TEVA Animal Health Inc., Saint Joseph, MO, by letters between May 1, 2009-May 7, 2009. Firm initiated recall is ongoing.

REASON

Some of the tablets have physical characteristic defects.

VOLUME OF PRODUCT IN COMMERCE

216,690/5-ct, 125,430/10-ct, 18,498/50-ct, 105,137/100-ct, 10,617/150-ct., 22,145/180-ct, 35,417/200-ct., 18,250/600-ct, and 25,527/1,000-ct

DISTRIBUTION

Nationwide

You can see which drug distributors contracted Teva to produce various drugs for them under the distributor/pharma name.