Drug recall D-0855-2020
Product
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.
Lots and codes
Lot #: H900330, exp. date 11/2020.
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 6,294 bottles
- Distribution
- Nationwide within the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 12, 2020
- Terminated
- June 3, 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.