CPSC official recall · 16232

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

召回日期：2016-07-27官方最后发布：2016-07-27适用地区：美国

重要：以下安全事实保留 CPSC 官方英文原文，避免翻译改变含义。请通过右侧官方公告确认行动要求。

危险说明 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.

受影响产品

Zolpidem Tartrate Sublingual tablets

Units：About 5,700 boxes of 30 blister packs

UPC

343386761012
343386762019

官方描述 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.

事故与伤害 Incidents / Injuries

None reported

官方补救措施 Remedy

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

Options：Refund

消费者联系信息

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.