Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teva Pharmaceuticals USA, Inc., originally initiated on 06-18-2013 for the product Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01 The product was recalled due to failed dissolution specifications: product is being recalled due to out of specification dissolution results obtained during routine stability testing.. The product was distributed nationwide and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-847-2013 | 06-18-2013 | 08-14-2013 | Class II | 16,293 bottles | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 20 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5346-01 | Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. | Terminated |
| D-849-2013 | 06-18-2013 | 08-14-2013 | Class II | 7,579 bottles | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 40 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5348-01 | Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. | Terminated |
| D-848-2013 | 06-18-2013 | 08-14-2013 | Class II | 13,478 bottles | Methylphenidate Hydrochloride Extended-Release Capsules (LA), 30 mg, 100 count bottle, Rx only, TEVA PHARMACEUTICALS USA, NDC 0093-5347-01 | Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing. | Terminated |
Recalled Products
