FDA Recall Methylphenidate Hydrochloride
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Methylphenidate Hydrochloride with NDC 62037-727 was initiated on 01-27-2020 as a Class II recall due to cgmp deviations: product bottle may be absent of desiccant. The latest recall number for this product is D-0837-2020 and the recall is currently terminated as of 11-03-2020 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0837-2020 | 01-27-2020 | 02-19-2020 | Class II | 17,436 bottles | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 27 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-734-01 | Terminated |
| D-0836-2020 | 01-27-2020 | 02-19-2020 | Class II | Methylphenidate hydrochloride Extended-Release ablets USP (CII), 18 mg, 100-count bottle, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 62037-725-01 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.