Medications & Supplements/Prescription Drugs

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

Agency Publication Date: July 27, 2016

Summary

Novel Laboratories is recalling approximately 5,700 boxes of Zolpidem Tartrate (Intermezzo) sublingual sleep tablets because the blister packaging is not child-resistant as required by federal law. The prescription medication is packaged in 30 unit-dose pouches per box and was sold at pharmacies including CVS, Costco, and Walgreens between March 2016 and May 2016. Because the packaging is easy for children to open, there is a serious risk of accidental ingestion. Consumers should stop using the tablets and contact the manufacturer for a full refund.

Risk

The drug packaging fails to meet child-resistant standards, allowing children to potentially open the blister packs and swallow the medication. This poses a significant risk of accidental poisoning for young children.

What You Should Do

Check your medication boxes and individual pouches for the brand name 'Gavis' and the drug name 'Zolpidem Tartrate Sublingual Tablet'.
Look for 1.75 mg tablets with NDC 43386-762-30, UPC 343386762019, and lot number M16140A.
Look for 3.5 mg tablets with NDC 43386-761-30, UPC 343386761012, and lot number M16144A.
Verify if the expiration date is 02/2018, which is printed on the bottom left of the individual pouches.
Immediately stop using the recalled medication and store it in a safe location out of reach of children.
Contact Novel Laboratories toll-free at 866-403-7592 from 9 a.m. to 5 p.m. ET Monday through Friday, or visit www.novellabs.net and click 'Important Zolpidem Information' to receive instructions for a full refund.
If you have additional questions, contact the CPSC Hotline at 800-638-2772.

Your Remedy Options

Full Refund

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

Contact: Novel Laboratories toll-free at (866) 403-7592 from 9 a.m. to 5 p.m. ET Monday through Friday or online at www.novellabs.net and click on "Important Zolpidem Information" for more information.

Affected Products

Product: Zolpidem Tartrate Sublingual Tablets (1.75 mg)

Model:

NDC 43386-762-30

UPC Codes:

343386762019

Lot Numbers:

M16140A

Date Ranges: Exp 02/2018, Sold March 2016 - May 2016

Product: Zolpidem Tartrate Sublingual Tablets (3.5 mg)

Model:

NDC 43386-761-30

UPC Codes:

343386761012

Lot Numbers:

M16144A

Date Ranges: Exp 02/2018, Sold March 2016 - May 2016

Product Images

Novel Laboratories sleep tablets 1.75 mg box (front)

Novel Laboratories sleep tablets 1.75 mg envelope (front)

Novel Laboratories sleep tablets 1.75 mg envelope (back)

Novel Laboratories sleep tablets 3.5 mg box (front)

Novel Laboratories sleep tablets 3.5 mg envelope (front)

Novel Laboratories sleep tablets 3.5 mg envelope (back)

Additional Information

Agency: Consumer Product Safety Commission (CPSC)

Recall ID: 16232

Status: Active

Manufacturer: Novel Laboratories, of Somerset, N.J.

Sold By: 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.

Distributor: Gavis Pharmaceuticals, of Somerset, N.J.

Manufactured In: United States

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

Distributed To: Nationwide

Agency Last Updated: July 27, 2016

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: CPSC Notice · Raw API Response

Summary

What You Should Do

Check your medication boxes and individual pouches for the brand name 'Gavis' and the drug name 'Zolpidem Tartrate Sublingual Tablet'.

Look for 1.75 mg tablets with NDC 43386-762-30, UPC 343386762019, and lot number M16140A.

Look for 3.5 mg tablets with NDC 43386-761-30, UPC 343386761012, and lot number M16144A.

Verify if the expiration date is 02/2018, which is printed on the bottom left of the individual pouches.

Immediately stop using the recalled medication and store it in a safe location out of reach of children.

Contact Novel Laboratories toll-free at 866-403-7592 from 9 a.m. to 5 p.m. ET Monday through Friday, or visit www.novellabs.net and click 'Important Zolpidem Information' to receive instructions for a full refund.

If you have additional questions, contact the CPSC Hotline at 800-638-2772.

Your Remedy Options

Full Refund

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

Affected Products

Product: Zolpidem Tartrate Sublingual Tablets (1.75 mg)

Model:

NDC 43386-762-30

UPC Codes:

343386762019

Lot Numbers:

M16140A

Date Ranges: Exp 02/2018, Sold March 2016 - May 2016

Product: Zolpidem Tartrate Sublingual Tablets (3.5 mg)

Model:

NDC 43386-761-30

UPC Codes:

343386761012

Lot Numbers:

M16144A

Date Ranges: Exp 02/2018, Sold March 2016 - May 2016

Additional Information

Agency: Consumer Product Safety Commission (CPSC)

Recall ID: 16232

Status: Active

Manufacturer: Novel Laboratories, of Somerset, N.J.

Sold By: 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.

Distributor: Gavis Pharmaceuticals, of Somerset, N.J.

Manufactured In: United States

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

Distributed To: Nationwide

Agency Last Updated: July 27, 2016