News From CPSC: 1 Recall Announced Today

 

-----------NEWS from CPSC-----------
U.S. Consumer Product Safety Commission
Office of Communications
4330 East West Highway, Bethesda, MD 20814
www.cpsc.gov

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

http://www.cpsc.gov/en/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs/

 

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

http://www.cpsc.gov/en/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs/

 

Recall Date: July 27, 2016

Recall Number: 16-232

   

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

http://www.cpsc.gov/en/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs/

 

Recall Summary

 

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

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

 

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

 

Photos Available At http://www.cpsc.gov/en/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs/

 

Units: About 5,700 boxes of 30 blister packs

 

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.

 

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: Novel Laboratories (a LUPIN Group Company), of Somerset, N.J.

 

Distributor: Gavis Pharmaceuticals (a LUPIN Group Company), of Somerset, N.J.

 

Manufactured in: U.S.

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The U.S. Consumer Product Safety Commission (CPSC) is still interested in receiving incident or injury reports that are either directly related to a product recall or involve a different hazard with the same product. Please tell us about your experience with the product on SaferProducts.gov.

 

Media Contact

Please use the phone numbers below for all media requests.

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Contact us at this toll-free number if you have questions about a recall:

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Times: 8 a.m. � 5:30 p.m. ET; Messages can be left anytime

Call to get product safety and other agency information and to report unsafe products.

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an independent federal regulatory agency, located at 4330 East West
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