FDAFDA · Food and drugs·Recall number D-1484-2014
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.
Published September 3, 2014 · Recall initiated: June 20, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurity/Degradation Specification; 12-month stability time point
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- FAMOTIDINE
- Manufacturer
- Novel Laboratories, Inc.
- Distributor
- Nationwide
- UPC
- 0343386500116
- Lot
- Lot #'s M13075A, M13076A, M13076B, M13077A, M13077B all with expiry dated 2/2015 and M13490A with expiry date 3/2016.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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