🔍 RecallPedia

Zolpidem Tartrate Sublingual tablets

Class II - Moderate
🏠 Consumer Products Recalled: July 27, 2016 Novel Laboratories, of Somerset, N.J. Furniture Nationwide

What Should You Do?

  1. Check if you have this product:
    (About 5,700 boxes of 30 blister packs)
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Report problems: Report any issues to the FDA's Safety Reporting Portal.

Recall Details

Company:
Novel Laboratories, of Somerset, N.J.
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.
Classification:
Class II - Moderate

Products that might cause a temporary health problem, or pose a slight threat of a serious nature.

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

Product Images

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Product Information

Full 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.

Product Codes/Lot Numbers:

(About 5,700 boxes of 30 blister packs)

Official Source

Always verify recall information with the official CPSC source:

View on CPSC.gov

CPSC Recall Number: 16232