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

  • 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)
  • Novel Laboratories sleep tablets 3.5 mg envelope (front)
  • Novel Laboratories sleep tablets 3.5 mg envelope (back)
Name of Product:
Zolpidem Tartrate Sublingual tablets
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
Recall Date:
July 27, 2016
Units:
About 5,700 boxes of 30 blister packs
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 Details

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.
Remedy:
Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.
Incidents/Injuries:
None reported
Sold At:
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.
Manufacturer(s):
Novel Laboratories, of Somerset, N.J.
Distributor(s):
Gavis Pharmaceuticals, of Somerset, N.J.
Manufactured In:
U.S.
Recall number:
16-232
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