Drug Safety Alerts

Zolpidem Tartrate Sublingual Tablets Consumer-Level Recall

05/10/2016


On May 10, 2016, Gavis Pharmaceuticals issued a consumer-level recall on zolpidem tartrate sublingual tablets. Gavis Pharmaceuticals issued this recall because its packaging for certain lots of the product may not meet the child-resistance standards as required by the Poison Prevention Packaging Act (PPPA). There is nothing wrong with the medication itself. The product continues to meet all quality requirements specified by the United States Food and Drug Administration (FDA). However, the manufacturer’s child-resistant packaging may not meet PPPA standards and therefore the manufacturer has warned of an increased chance that young children could gain unintended access, which could pose potential harm to the children.

A complete list of the affected products and lot numbers is provided here:

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of the manufacturer’s recall.

For more information, health care providers may contact Gavis Pharmaceuticals at 1‑908‑603‑6080 or visit their web site at www.gavispharma.com/.