Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning
USNovel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning
Recalling Firm: Novel Laboratories, of Somerset, N.J.
Reason for Recall / 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.
Product Description & Identification
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.
Affected Products
Zolpidem Tartrate Sublingual tablets
Additional Source Details
| Field | Value |
|---|---|
| U R L | https://www.cpsc.gov/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs |
| Title | Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning |
| Images › 1 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232a.jpg |
| Images › 1 › Caption | Novel Laboratories sleep tablets 1.75 mg box (front) |
| Images › 2 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232b.jpg |
| Images › 2 › Caption | Novel Laboratories sleep tablets 1.75 mg envelope (front) |
| Images › 3 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232c.jpg |
| Images › 3 › Caption | Novel Laboratories sleep tablets 1.75 mg envelope (back) |
| Images › 4 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232d.jpg |
| Images › 4 › Caption | Novel Laboratories sleep tablets 3.5 mg box (front) |
| Images › 5 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232e.jpg |
| Images › 5 › Caption | Novel Laboratories sleep tablets 3.5 mg envelope (front) |
| Images › 6 › U R L | https://www.cpsc.gov/s3fs-public/Recall.2016.16232.16232f.jpg |
| Images › 6 › Caption | Novel Laboratories sleep tablets 3.5 mg envelope (back) |
| Hazards › Name | 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. |
| Injuries › Name | None reported |
| Products › Name | Zolpidem Tartrate Sublingual tablets |
| Products › Type | Tablet or Capsule Drugs |
| Products › Category I D | 68198 |
| Products › Number Of Units | About 5,700 boxes of 30 blister packs |
| Recall I D | 7814 |
| Remedies › Name | Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund. |
| Retailers › Name | 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. |
| Recall Date | 2016-07-27T00:00:00 |
| 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 U P Cs › 1 › U P C | 343386761012 |
| Product U P Cs › 2 › U P C | 343386762019 |
| Distributors › Name | Gavis Pharmaceuticals, of Somerset, N.J. |
| Recall Number | 16232 |
| Manufacturers › Name | Novel Laboratories, of Somerset, N.J. |
| Remedy Options › Option | Refund |
| Consumer 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. |
| Last Publish Date | 2016-07-27T00:00:00 |
| Manufacturer Countries › Country | United States |
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Overview
- Recalling FirmNovel Laboratories, of Somerset, N.J.
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🚨 SAFETY ALERT: Novel Laboratories, of Somerset, N.J. - Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning Check if your household is affected: https://therecallfile.com/recalls/novel-laboratories-recalls-zolpidem-tartrate-blister-packs-due-to-fail/CPSC-16232
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