Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Impurity/Degradation Specification; 12-month stability time point
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Reason Presence of Foreign Tablet/Capsule: A stray Rasagiline Mesylate 1 mg tablet was discovered in an unopened bottle of Ibuprofen and Famotidine.
Reason Labeling: Label Error on Declared Strength: some cartons labeled and containing 20 mg may have an external label placed on the side of the carton…
Reason Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg.
Reason TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerated state.
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