Drug recall D-1484-2014

Class III Terminated reported Sep 3, 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.

Reason for recall

Failed Impurity/Degradation Specification; 12-month stability time point

Lots and codes

Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.

Recall details

Recalling firm
Novel Laboratories, Inc., Somerset, NJ
Quantity
25,776 containers
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
June 20, 2014
Terminated
June 29, 2015

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