Recall: D-0629-2020

Class III - Minor Violations

Class IIIClassification

2019-12-10Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

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

Failed Dissolution Specifications: High out of specification result observed at stability studies.

Distribution

Nationwide in the USA

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