Novel Laboratories Recalls Zolpidem Tartrate Tablets for Packaging Defect

Plain-English summary

Novel Laboratories is recalling approximately 5,700 boxes of 30 blister packs of Zolpidem Tartrate sublingual tablets in 1.75 mg and 3.5 mg strengths. The recall is due to the packaging failing to meet the child-resistant closure requirements of the Poison Prevention Packaging Act. The medication is a prescription sleep drug packaged in peel-and-push blister packs inside an outer open-ended pouch.

The affected 1.75 mg tablets have lot number M16140A and NDC 43386-762-30. The affected 3.5 mg tablets have lot number M16144A and NDC 43386-761-30. The packaging features the word "Gavis" printed in blue on white boxes and pouches, with an expiration date of 02/2018. The products were sold at clinics and pharmacies nationwide, including CVS, Costco, Walgreens, Kroger, and Wegmans, from March 2016 through May 2016.

Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund. The company can be reached toll-free at (866) 403-7592 from 9 a.m. to 5 p.m. ET Monday through Friday, or online at www.novellabs.net.

The recalled product

Product

Zolpidem Tartrate Sublingual tablets

Manufacturer

Novel Laboratories, of Somerset, N.J.

Category

Drug — Prescription Medication

Hazard

• poisoning
• child-access

Affected units

5,700

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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