Drug product
Methylphenidate Hydrochloride Tablets USP, 20 mg, 100-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA, NDC 0591-5884-01.
D-0052-2018
Product summary
- Event
- Event 78308
- Status
- Terminated
- Classification
- Class III
- Quantity
- 58,292 bottles
- Official record key
drug-enforcement:D-0052-2018
Official wording
Reason: Failed Dissolution Specifications: Low out of specification results for dissolution.
Code information: Lot Number # 1156086M, Exp 08/18
Distribution pattern: Nationwide in the USA and Puerto Rico
Derived failure modes
-
Potency or specification failure
out of specification