Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30

FDA recall notice · announced July 29, 2015 · Purdue Pharma L.p

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30

Reason for recall

Failed dissolution specifications

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot # 3122833A, Expiry 5/31/16
Quantity: 6,264 cartons (30 sublingual tablets in 1 carton)
Status: Terminated
Products in this recall event:
- Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only, Distributed by Purdue Pharma L.P. Stamford, CT 06901-3431, NDC 59011-265-30 (D-1278-2015)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.