FDA recall D-1484-2014

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.

Reason for recall

Failed Impurity/Degradation Specification; 12-month stability time point

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-06-20

Report date

2014-09-03

Termination date

2015-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1484-2014