Recall: D-0855-2020

Class II - Potentially Harmful

Class IIClassification

2020-02-12Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

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

Failed Dissolution Specifications: Low out of specification results observed in dissolution test at six-month long-term stability study.

Distribution

Nationwide within the United States.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.