PlainRecalls
FDA Drug Low Class III Terminated

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

Reported: September 13, 2017 Initiated: May 2, 2017 #D-1127-2017

Product Description

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 for Recall

CGMP Deviations

Details

Units Affected
12,888 bottles
Distribution
Nationwide in the USA
Location
Baltimore, MD

Frequently Asked Questions

What product was recalled?
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. Recalled by Lupin Pharmaceuticals Inc.. Units affected: 12,888 bottles.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on September 13, 2017. Severity: Low. Recall number: D-1127-2017.