Drug product
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
D-0629-2020
Product summary
- Event
- Event 84463
- Status
- Terminated
- Classification
- Class III
- Quantity
- 3,726 bottles
- Official record key
drug-enforcement:D-0629-2020
Official wording
Reason: Failed Dissolution Specifications: High out of specification result observed at stability studies.
Code information: Lot #: H901787, H901788, Exp March 2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification