Drug product
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
D-0836-2020
Product summary
- Event
- Event 84797
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-0836-2020
Official wording
Reason: CGMP deviations: Product bottle may be absent of desiccant.
Code information: Lot #: 1332796 A, Exp 11/2020
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP deviations