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Product Recall Number: 16-232

Why was Zolpidem Tartrate Sublingual tablets 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.

Zolpidem Tartrate Sublingual tablets
Here's product recall specific data for Zolpidem Tartrate Sublingual tablets.

  • Product Recall Number: 16-232

  • Product Safety Warning Number:

  • Date: 2016-07-27

  • Product Safety Warning Date:

  • Name Of Product: Zolpidem Tartrate Sublingual tablets

  • Description: The packaging for the prescription drug is not child-resistant as required by the Poison Prevention Packaging Act.

  • Hazard Description: 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.

  • Consumer Action: None Listed

  • Original Product Safety Warning Announcement: None Listed

  • Remedy Type: Refund

  • Units: About 5,700 boxes of 30 blister packs

  • Incidents: None reported

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

  • 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."

  • Importers: None Listed

  • Manufacturers: "Novel Laboratories, of Somerset, N.J."

  • Distributors: "Gavis Pharmaceuticals, of Somerset, N.J."

  • Manufactured In: U.S.

  • Custom Label: None Listed

  • Custom Field: None Listed