drugs Class III Updated 2014-09-03

Novel Laboratories, Inc. recalls Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Che

Recalled 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.

Hazard / Issue

Failed Impurity/Degradation Specification; 12-month stability time point

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
View official government recall

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