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

FDA recall notice · announced February 19, 2020 · Lupin Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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.

Notes

Distribution: Nationwide within the United States.
Lot/code information: Lot #: H900330, exp. date 11/2020.
Quantity: 6,294 bottles
Status: Terminated
Products in this recall event:
- 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 Limit (D-0855-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.