Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning

Recall at a glance

What was recalled

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.

Is my product affected?

Compare your product with the details below, including model numbers where listed.

• Zolpidem Tartrate Sublingual tablets · About 5,700 boxes of 30 blister packs units

Photos from the recall notice

Where it was sold

Companies named in the notice: Clinics and pharmacies nationwide, including CVS, Costco, Walgreens, Kroger, and Wegmans from March 2016 through May 2016 for about $800 per box of 30 tablets.; Novel Laboratories, of Somerset, N.J.; Gavis Pharmaceuticals, of Somerset, N.J..

Consumer contact

Novel Laboratories toll-free at (866) 403-7592 from 9 a.m. to 5 p.m. ET Monday through Friday or online at www.novellabs.net and click on "Important Zolpidem Information" for more information.

Recall history and context

Since 2019 CPSC has recorded 36 recalls in the phones, computers and electronics category, 5 recalls of them in the past 12 months.

Frequently asked questions

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