WASHINGTON, July 27, 2016 /PRNewswire-USNewswire/ -- http://www.cpsc.gov/en/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs/
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.
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.
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.
About U.S. CPSC:
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of injury or death associated with the use of thousands of types of consumer products under the agency's jurisdiction. Deaths, injuries, and property damage from consumer product incidents cost the nation more than $1 trillion annually. CPSC is committed to protecting consumers and families from products that pose a fire, electrical, chemical or mechanical hazard. CPSC's work to ensure the safety of consumer products - such as toys, cribs, power tools, cigarette lighters and household chemicals – contributed to a decline in the rate of deaths and injuries associated with consumer products over the past 40 years.
Federal law bars any person from selling products subject to a publicly-announced voluntary recall by a manufacturer or a mandatory recall ordered by the Commission.
To report a dangerous product or a product-related injury go online to www.SaferProducts.gov or call CPSC's Hotline at 800-638-2772 or teletypewriter at 301-595-7054 for the hearing impaired. Consumers can obtain news release and recall information at www.cpsc.gov, on Twitter @USCPSC or by subscribing to CPSC's free e-mail newsletters.
CPSC Consumer Information Hotline
Contact us at this toll-free number if you have questions about a recall:
800-638-2772 (TTY 301-595-7054)
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.
Please use the phone numbers below for all media requests.
To view the original version on PR Newswire, visit:http://www.prnewswire.com/news-releases/novel-laboratories-recalls-zolpidem-tartrate-blister-packs-due-to-failure-to-meet-child-resistant-closure-requirement-risk-of-poisoning-300304840.html
SOURCE U.S. Consumer Product Safety Commission