Drug 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.
D-1484-2014
Product summary
- Event
- Event 68722
- Status
- Terminated
- Classification
- Class III
- Quantity
- 25,776 containers
- Official record key
drug-enforcement:D-1484-2014
Official wording
Reason: Failed Impurity/Degradation Specification; 12-month stability time point
Code information: Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Impurity/Degradation Specification