Zolpidem Tartrate (Novel Labs) – Child Safety Issue (2016)

Check Your Product

According to the U.S. Consumer Product Safety Commission (CPSC)

Product Images

Source: U.S. Consumer Product Safety Commission

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Reason for Recall

As stated by CPSC

This recall involves 1.75 mg and 3.5 mg Zolpidem Tartrate sublingual (rapid dissolve) tablets from Novel Laboratories. The prescription medication is a sleep drug. The packaging for the 1.75 mg tablets has lot number M16140A, 1.75 mg and national drug code (NDC) 43386-762-30. The packaging for the 3.5 mg tablets has lot number M16144A, 3.5mg and national drug code (NDC) 43386-761-30. The Zolpidem Tartrate is packaged as a single tablet in a peel-and-push blister pack inside an outer open-ended pouch with 30 pouches per box. The lot number and an expiration date of 02/2018 are printed on the bottom left of the pouches. The NDC is printed on the top left corner of the boxes. "Gavis" is printed in blue on the center of the white boxes and pouches.

Recommended Action

Per CPSC guidance

Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.