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Drug Safety Alerts

Enalapril Tablets Voluntary Recall

3/16/2022

On March 16, 2022, Golden State Medical Supply (GSMS) issued a consumer-level recall of multiple lots of Enalapril 2.5mg, 5mg, 10mg and 20mg tablets manufactured by Taro Pharmaceuticals and distributed by GSMS. According to GSMS, this recall was issued as a precautionary measure due to a confirmed out-of-specification (OOS) result for an unknown impurity in one lot. The specification limit for any unknown impurity is no more than (NMT) 0.2%, however, the test result was 0.54%. GSMS has advised that all other results were within specification.

This could be a health hazard or safety risk to patients using product affected by this recall.

A list of the affected products is provided here.

CVS Caremark Response: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

For more information, please call Golden State Medical Supply toll-free at 1-800-284-8633, 7:30 AM to 4:00 PM (PT) or email recalls@gsms.us. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.