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

Recalled July 27, 2016 · CPSC recall 16232 · Novel Laboratories

Novel Laboratories sleep tablets 1.75 mg box (front)Novel Laboratories sleep tablets 1.75 mg envelope (front)Novel Laboratories sleep tablets 1.75 mg envelope (back)Novel Laboratories sleep tablets 3.5 mg box (front)
Hazard
The packaging for the prescription drug is not child-resistant as required by the Poison Prevention Packaging Act, posing a risk of poisoning if swallowed by children.
Remedy
Refund
Units
About 5,700 boxes of 30 blister packs
Incidents / injuries
None reported

Description

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.

What to do

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

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.

Product
Zolpidem Tartrate Sublingual tablets
Manufacturer(s)
Novel Laboratories, of Somerset, N.J.
Distributed by
Gavis Pharmaceuticals, of Somerset, N.J.
Retailers
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.
Made in
United States
UPC
343386761012 · 343386762019

Source: U.S. Consumer Product Safety Commission. Official recall notice on cpsc.gov →