D-0629-2020 Class III Terminated
FDA drug recall D-0629-2020 was initiated by Lupin Pharmaceuticals Inc. on December 10, 2019 and is designated Class III. Reason for recall: Failed Dissolution Specifications: High out of specification result observed at stability studies. The recall status is terminated (terminated April 29, 2021). Affected quantity: 3,726 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 25, 2019
- Initiation Date
- December 10, 2019
- Termination Date
- April 29, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,726 bottles
Product Description
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.
Distribution Pattern
Nationwide in the USA
Code Information
Lot #: H901787, H901788, Exp March 2021