Recall: D-1484-2014

Class III - Minor Violations

Class IIIClassification

2014-06-20Initiated

TerminatedStatus

Novel Laboratories, Inc.Firm

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

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

Distribution

Nationwide

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.