| Product name |
Zolpidem Tartrate Sublingual tablets |
| 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. |
| Problem |
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. |
| Distribution |
Clinics and pharmacies nationwide, including CVS, Costco, Walgreens, Kroger, and Wegmans for about $800 per box of 30 tablets. |
| Company |
Novel Laboratories 866-403-7592; website www.novellabs.net |
| Dates sold |
March 2016 through May 2016 |
| Date posted |
07/28/2016 |
| Additional information |
For additional information, visit the U.S. Consumer Product Safety Commission's news release at www.cpsc.gov/en/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs/ |
| Image |
|
|
|
