June 2014 FDA Recall Famotidine by Novel Laboratories, Inc.
D-1484-2014 - Failed Impurity/Degradation Specification; 12-month stability time point

This Class III drug recall was voluntarily initiated by Novel Laboratories, Inc. on June 20, 2014 for the product Famotidine. The FDA reported the reason for recall as failed impurity/degradation specification; 12-month stability time point. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1484-2014

Reason for Recall
Failed Impurity/Degradation Specification; 12-month stability time point
Initiated
06-20-2014
Reported
09-03-2014
Quantity
25,776 containers

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
68722
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Novel Laboratories, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
06-29-2015
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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

Affected Packages Involved in this Recall

43386-500-11 Famotidine