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Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning is CPSC recall #16232, announced on July 27, 2016. The CPSC cites the following hazard: 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. The remedy is consumers should immediately stop using the recalled tablets and contact novel laboratories for instructions to receive a full refund.. Affected brands: Novel Laboratories, Gavis Pharmaceuticals.
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
Recalled brands
Novel Laboratories, Gavis Pharmaceuticals
Remedy
Consumers should immediately stop using the recalled tablets and contact Novel Laboratories for instructions to receive a full refund.
Recall date
July 27, 2016
CPSC recall #16232 covers Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning, announced by the U.S. Consumer Product Safety Commission on July 27, 2016. The CPSC cites the following hazard: 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.
The CPSC remedy for recall #16232 is consumers should immediately stop using the recalled tablets and contact novel laboratories for instructions to receive a full refund.. Consumers should stop using the product and follow the instructions in the official CPSC notice.
If you sell Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child-Resistant Closure Requirement; Risk of Poisoning on Shopify, stop selling the affected units immediately, notify customers who purchased them, and consider whether you have a Section 15(b) reporting obligation to the CPSC. RecallDocket helps Shopify merchants identify affected SKUs and prepare the required safety report.
The primary source is the official CPSC notice at https://www.cpsc.gov/Recalls/2016/Novel-Laboratories-Recalls-Zolpidem-Tartrate-Blister-Packs. RecallDocket links to it from this page.
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