Recall: Novel Laboratories Zolpidem Tartrate Sublingual Tablets
On 2016-07-27, the Consumer Product Safety Commission (CPSC) published a recall regarding Novel Laboratories Zolpidem Tartrate Sublingual Tablets due to a potential Poisoning hazard. This product sold new beginning in March 2016 for about $800.
About 6,000 units are involved in this Novel Laboratories tablet recall. Learn more and find out what to do if you own this product below.
This was the 1st recall of products in the Medication category in 2016.
Company Contact Information:
Phone: (866) 403-7592
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What is the 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.
How can I tell if I own this product?
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.
These items were sold new+ at 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.
What should I do if I own this recalled product?
First, stop using the item.
Then, add the item to a free, private Items I Own account. This will enable you to easily access the CPSC and recalling company's remedy instructions as well as track your progress toward getting the item returned or fixed. Click "I Own THIS Item" to continue.
The CPSC provides the following remedy information:
Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.
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 "Important Zolpidem Information"¯ for more information.
Incidents & Injuries Reported as of Recall Date
+WeMakeItSafer cautions consumers that recalled items may have been acquired at different locations, prices and times than specified in the CPSC recall announcement. This is especially true for items purchased in online marketplaces, resale shops or yard sales. More information may be available at CPSC.gov.
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Sources may include: Consumer Product Safety Commission (CPSC), Health Canada and companies involved with this or a related recall.