Class III
Terminated
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
- Company
- Lupin Pharmaceuticals Inc.
- Recall Initiated
- December 10, 2019
- Posted
- December 25, 2019
- Recall Number
- D-0629-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 3,726 bottles
- Firm Location
- Baltimore, MD, United States
Reason for Recall
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: H901787, H901788, Exp March 2021
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