Drug recall
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson…
FDA recall event 78308 · Class III · Teva Pharmaceuticals USA
Key facts
| Event ID | 78308 |
|---|---|
| Recall numbers | D-0052-2018 |
| Recalling firm | Teva Pharmaceuticals USA |
| Product type | Drugs |
| Products | Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01. |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Failed Dissolution Specifications: Low out of specification results for dissolution. |
| Initiation date | Oct 17, 2017 |
| Report date | Nov 1, 2017 |
| Termination date | Apr 12, 2018 |
| City | North Wales |
| State | PA |
| Country | United States |
| FEI number | 3003092769 |
At a glance
- 1–9 Products in this recall
- 1–9 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 · Source date: