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.
Reason for recall: Failed Impurity/Degradation Specification; 12-month stability time point
Recall initiated: 20140620
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated