FDA-Drug2014-09-03Class III
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.
Novel Laboratories, Inc.
Hazard
Failed Impurity/Degradation Specification; 12-month stability time point
Sold states
Nationwide
Affected count
25,776 containers
Manufactured in
400 Campus Dr, N/A, Somerset, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1484-2014Don't want to check this manually?
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