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.
Reported: September 3, 2014 Initiated: June 20, 2014 #D-1484-2014
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
Details
- Recalling Firm
- Novel Laboratories, Inc.
- Units Affected
- 25,776 containers
- Distribution
- Nationwide
- Location
- Somerset, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Novel Laboratories, Inc.. Units affected: 25,776 containers.
Why was this product recalled? ▼
Failed Impurity/Degradation Specification; 12-month stability time point
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 3, 2014. Severity: Low. Recall number: D-1484-2014.
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