Class III
Terminated
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.
- Company
- Novel Laboratories, Inc.
- Recall Initiated
- June 20, 2014
- Posted
- September 3, 2014
- Recall Number
- D-1484-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 25,776 containers
- Firm Location
- Somerset, NJ, United States
Reason for Recall
Failed Impurity/Degradation Specification; 12-month stability time point
Distribution
Nationwide
Lot / Code Info
Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
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