D-0855-2020 Class II Terminated
FDA drug recall D-0855-2020 was initiated by Lupin Pharmaceuticals Inc. on February 12, 2020 and is designated Class II. Reason for recall: Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study. The recall status is terminated (terminated June 3, 2021). Affected quantity: 6,294 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 19, 2020
- Initiation Date
- February 12, 2020
- Termination Date
- June 3, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6,294 bottles
Product Description
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
Reason for Recall
Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.
Distribution Pattern
Nationwide within the United States.
Code Information
Lot #: H900330, exp. date 11/2020.