Drug recall D-0629-2020
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
Reason for recall
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Lots and codes
Lot #: H901787, H901788, Exp March 2021
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 3,726 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 10, 2019
- Terminated
- April 29, 2021
Related products
- Memantine hydrochloride – drug information
- NDC 68180-247 Memantine hydrochloride · Memantine Hydrochloride 14 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-246 Memantine hydrochloride · Memantine Hydrochloride 7 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-249 Memantine hydrochloride · Memantine Hydrochloride 28 mg/1 · Lupin Pharmaceuticals, Inc.
- NDC 68180-248 Memantine hydrochloride · Memantine Hydrochloride 21 mg/1 · Lupin Pharmaceuticals, Inc.