Faulty Child-Resistant Packaging Leads to Sleep Aid Recall

About 5,700 boxes are included in the recall from novel laboratories

Faulty Child-Resistant Packaging Leads to Sleep Aid Recall
Image: NCCC
July 27, 2016

Novel Laboratories has announced a recall for a product with defective child-resistant packaging.

The company is recalling 30 count blister packs of 1.75 mg and 3.5 mg Zolpidem Tartrate sublingual (rapid dissolve) tablets, a prescription sleep aid. The packaging for the drug is not child-resistant as required by the Poison Prevention Packaging Act, posing a risk of poisoning if swallowed by children. About 5,700 boxes are included in the recall.

No incidents or injuries have been reported in connection with this product.

The packaging for the 1.75 mg tablets bears lot number M16140A, 1.75 mg, and national drug code (NDC) 43386-762-30. The packaging for the 3.5 mg tablets bears lot number M16144A, 3.5mg, and 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.

Individuals could purchase the drugs at clinics andpharmacies nationwide, including CVS, Costco, Walgreens, Kroger, and Wegmans from March 2016 through May 2016 for about $800 per box of 30 tablets.

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

Customers with questions about this recall can contact Novel Laboratories at (866) 403-7592.