Novel Laboratories, Inc. recalls Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by
Recalled September 3, 2014 · FDA recall D-1484-2014 · Novel Laboratories
Hazard
Failed Impurity/Degradation Specification; 12-month stability time point · FDA Class III
Units
25,776 containers
Sold at
Nationwide
Description
Failed Impurity/Degradation Specification; 12-month stability time point
Product
Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured by: Novel Laboratories, Inc., Somerset, NJ 08873. Distributed by: Gavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11.
Manufacturer(s)
Novel Laboratories, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →