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Product recall · CPSCJuly 27, 2016Worth checking
Novel Laboratories Zolpidem Tartrate Blister Packs
The notice says to stop using it — see below for what to do.
What’s wrong
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.
The Recall Registry rates this worth checking — we found nothing in the notice describing a specific injury. A recall covers only the versions, UPCs or date codes it names, so check those against yours.
What it looks like
Photos help. Identifiers decide. Appearance can vary by color, finish or packaging. Confirm the model number, date code or other identifier in the official notice.
Recall image provided by CPSC
What to do
Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.
Who to 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.
The product
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.
Details
- Units affected
- About 5,700 boxes of 30 blister packs
- Recall date
- July 27, 2016
- Brand
- Novel Laboratories, of Somerset, N.J.
- Made or distributed by
- Gavis Pharmaceuticals, of Somerset, N.J.
- Injuries reported
- None reported
M16140AM16144A
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.
The official notice
This recall was issued by the U.S. Consumer Product Safety Commission. The Recall Registry summarises it — always confirm the details at the source.
Their exact wording: “Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning”
Worried about the other things in your house? You can write down what you have and be told if one is recalled — or, if you sell second-hand, check your whole stock at once.
Filed under: Cleaning & chemicals