Recall: D-1127-2017

Class III - Minor Violations

Class IIIClassification

2017-05-02Initiated

TerminatedStatus

Lupin Pharmaceuticals Inc.Firm

Product

Famotidine for Oral Suspension USP, 40 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Goa 403 722 INDIA, NDC 68180-150-01

Reason

CGMP Deviations

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.