Drug recall
AgriLabs Prohibit (Levamisole Hydrochloride) Soluble Drench Powder, contains 46.8 grams of levamisole…
FDA recall event 53786 · Class II · TEVA Animal Health Inc
Key facts
| Event ID | 53786 |
|---|---|
| Recall numbers | V-077-2010, V-078-2010, V-079-2010, V-080-2010, V-081-2010, V-082-2010, V-083-2010, V-084-2010, V-085-2010, V-086-2010, V-087-2010, V-088-2010 and 80 more |
| Recalling firm | TEVA Animal Health Inc |
| Product type | Veterinary |
| Products | AgriLabs Prohibit (Levamisole Hydrochloride) Soluble Drench Powder, contains 46.8 grams of levamisole hydrochloride activity, packaged in 1.8-oz. packets, OTC, ANADA 200-386, Manufactured for Agri…, Amino acid concentrate oral solution, each 100 ml of aqueous solution contains 5 g dextrose hydrate, 250 mg sodium acetate trihydrate, 200 mg magnesium sulfate heptahydrate, 200 mg potassium chloride…, Amino acid oral solution, each 100 ml. of aqueous solution contains 5 g dextrose hydrate, 250 mg sodium acetate trihydrate, 20 mg magnesium sulfate heptahydrate, 20 mg potassium chloride, 15 mg…, Amprolium 9.6% Oral Solution, packaged in 32-fl. oz. bottles (TEVA brand only) and 1-gal bottles, OTC, ANADA 200-389, packaged under the following product names and labels: (1) TEVA Amprolium 9.6%…, AmTech Group, Inc. Gentamicin Sulfate Pig Pump Oral Solution, each ml contains gentamicin sulfate equivalent to 5 mg gentamicin, packaged in 118-ml bottles, OTC, ANDA 200-174, Manufactured by IVX… and 87 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | FDA Requested |
| Reason for recall | The products were not manufactured in conformance with GMP's |
| Initiation date | Sep 4, 2009 |
| Termination date | Aug 18, 2011 |
| City | Saint Joseph |
| State | MO |
| Country | United States |
| FEI number | 1000118231 |
At a glance
- 10–99 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports