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

Reported: July 27, 2016 Initiated: July 27, 2016 #16232

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.

Reason for Recall

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

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

Details

Units Affected
About 5,700 boxes of 30 blister packs
Official Source
https://www.cpsc.gov/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Novel Laboratories, of Somerset, N.J.. Units affected: About 5,700 boxes of 30 blister packs.
Why was this product 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 consumers do? ▼
Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.
Which agency issued this recall? ▼
This recall was issued by the CPSC on July 27, 2016. Severity: Moderate. Recall number: 16232.

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