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Recall Details


Novel Laboratories Recalls Zolpidem Tartrate Blister Packs Due to Failure to Meet Child- ...


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:
Zolpidem Tartrate Sublingual tabletsType : Tablet or Capsule DrugsCategoryID : 68198About 5,700 boxes of 30 blister packs
Retailer:
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.CompanyID : 0
Distributor:
Gavis Pharmaceuticals, of Somerset, N.J.CompanyID : 0
Recall Date:    Jul 27, 2016
Injury:
None reported
Mfg:
Novel Laboratories, of Somerset, N.J.CompanyID : 0
Mfg Country:
United States
Recall ID:    7814
Last Published:    Jul 27, 2016
Official Site:    Link

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RecallMe Number:    16232
RecallMe Status:    Announced
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