Recalls / Class III
Class IIID-1484-2014
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.
- Brand name
- Famotidine
- Generic name
- Famotidine
- Active ingredient
- Famotidine
- Route
- Oral
- NDC
- 43386-500
- FDA application
- ANDA201695
- Affected lot / code info
- Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
Why it was recalled
Failed Impurity/Degradation Specification; 12-month stability time point
Recalling firm
- Firm
- Novel Laboratories, Inc.
- Manufacturer
- Lupin Pharmaceuticals,Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Campus Dr, N/A, Somerset, New Jersey 08873-1145
Distribution
- Quantity
- 25,776 containers
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-06-20
- FDA classified
- 2014-08-22
- Posted by FDA
- 2014-09-03
- Terminated
- 2015-06-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1484-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.