Drug product
Memantine Hydrochloride Extended Release Capsules, 21 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States. Manufactured by: Lupin Limited Pithampur (M.P.)-454 775, INDIA, NDC 68180-248-06
D-0855-2020
Product summary
- Event
- Event 84948
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6,294 bottles
- Official record key
drug-enforcement:D-0855-2020
Official wording
Reason: Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Code information: Lot #: H900330, exp. date 11/2020.
Distribution pattern: Nationwide within the United States.
Derived failure modes
-
Potency or specification failure
out of specification