Drug recall
Levoxyl (R) (levothyroxine sodium tablets, USP), 112mcg, 100 and 1000-count bottles, Rx Only, Mfg. by JONES…
FDA recall event 36016 · Class II · King Pharmaceuticals Inc
Key facts
| Event ID | 36016 |
|---|---|
| Recall numbers | D-332-6, D-333-6, D-334-6 |
| Recalling firm | King Pharmaceuticals Inc |
| Product type | Drugs |
| Products | Levoxyl (R) (levothyroxine sodium tablets, USP), 112mcg, 100 and 1000-count bottles, Rx Only, Mfg. by JONES PHARMA INC. (a wholly owned subsidiary of King Pharmaceuticals, Inc.), Bristol, VA 24201…, Levoxyl (R) (levothyroxine sodium tablets, USP), 125mcg, 100 and 1000-count bottles, Rx Only, Mfg. by JONES PHARMA INC. (a wholly owned subsidiary of King Pharmaceuticals,Inc.), Bristol, VA 24201…, Levoxyl (R) (levthyroxine sodium tablets, USP), 75mcg, 100-count bottles, Rx Only, Mfg. by JONES PHARMA INC. (a wholly owned subsidiary of King Pharmaceuticals, Inc.), Bristol, VA 24201, NDA: 201-301… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential sub-potency at 15-month stability interval, Potential sub-potentcy at 15-month stability interval |
| Initiation date | Aug 1, 2006 |
| Termination date | Aug 24, 2007 |
| City | Bristol |
| State | TN |
| Country | United States |
| FEI number | 1000208638 |
At a glance
- 1–9 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