D-1484-2014 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 3, 2014
- Initiation Date
- June 20, 2014
- Termination Date
- June 29, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 25,776 containers
Product Description
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
Distribution Pattern
Nationwide
Code Information
Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.