Key Takeaway

Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning by Novel Laboratories, of Somerset, N.J. was recalled on July 27, 2016. What to do: Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.

CPSC Ongoing

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

Recalled: July 27, 2016 ~About 5,700 boxes of 30 blister packs units affected 16232

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.

Injuries / Consequence

None reported

Remedy

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

Products Affected

Zolpidem Tartrate Sublingual tablets

Tablet or Capsule Drugs

Images

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

Company Information

Novel Laboratories, of Somerset, N.J.

Unknown location

View all 1 recalls by Novel Laboratories, of Somerset, N.J. →

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Frequently Asked Questions

Is this recall still active?

Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.

How do I check if my product is affected?

Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.

What remedy is available for this recall?

The listed remedy for this recall is: Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.

Where can I find the original recall notice?

This recall was issued by CPSC. You can view the original notice using the link provided above.

Data sourced from Consumer Product Safety Commission. Recall information may not reflect the most current status. RecallDex is not affiliated with any US government agency. Contact the manufacturer or relevant agency for the latest information.