Novel Laboratories Zolpidem Tartrate Blister Packs recall: Failure to Meet Child-Resistant Closure
Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning
Why was Novel Laboratories Zolpidem Tartrate Blister Packs recalled?
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.
What should I do if I have this product?
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.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official CPSC record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UPC: 343386761012, 343386762019
- Product
- Zolpidem Tartrate Sublingual tablets
- Company
- Novel Laboratories, of Somerset, N.J., Gavis Pharmaceuticals, of Somerset, N.J.
- Quantity
- About 5,700 boxes of 30 blister packs
- 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.
- Recall date
- July 27, 2016
- Incidents / injuries
- None reported
- Agency
- CPSC
Product 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.