Drug product
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
D-0837-2020
Product summary
- Event
- Event 84797
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,436 bottles
- Official record key
drug-enforcement:D-0837-2020
Official wording
Reason: CGMP deviations: Product bottle may be absent of desiccant.
Code information: Lot # 1332799A, Exp 11/2020
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP deviations