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Medication Safety Alerts

Zolpidem Tartrate Sublingual Tablets Voluntary Recall

05/10/2016

On May 10, 2016, Gavis Pharmaceuticals issued a voluntary recall on zolpidem tartrate sublingual tablets.Gavis Pharmaceuticals issued this recall because its packaging for certain lots 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 meets all quality requirements specified by the United States Food and Drug Administration (FDA). Because the manufacturer’s child-resistance packaging may not meet PPPA standards, there is an increased chance that young children could access the medication, which could harm the children.

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

To see if you received product from these affected lots, please check the lot number. The lot number can be found on the carton as well as the individual blister product. If your product is not from these affected lots, it is not affected by this recall. If your product is from one of these affected lots, please contact the pharmacy that filled your prescription for further instructions.

CVS Caremark Response: If you are currently taking zolpidem tartrate sublingual tablets from the affected lots, please call a Customer Care representative toll-free at 1‑866-823-5184.

If you are currently taking zolpidem tartrate sublingual tablets and have questions regarding this recall, please call your doctor or call Gavis Pharmaceuticalsat 1‑908‑603‑6080 or visit www.gavispharma.com.

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