Reported Sep 3, 2014 · Terminated
Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection, Manufactured…
Novel Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Novel Laboratories, Inc. · 400 Campus Dr · Somerset, NJ · 08873-1145
Is this the product you have?
- Famotidine for Oral Suspension, USP 40 mg/5 mL, Rx Only, Cherry-Banana-Mint Flavored, Not for Injection
- Manufactured byNovel Laboratories, Inc., Somerset, NJ 08873
- Distributed byGavis Pharmaceuticals, LLC, Somerset, NJ 08873, NDC 43386-500-11
- Lot codes and dates
- Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
- Amount recalled
- 25,776 containers
Where it was sold
- Nationwide
Why it was recalled
Failed Impurity/Degradation Specification; 12-month stability time point
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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