Drug 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
D-1278-2015
Product summary
- Event
- Event 71732
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6,264 cartons (30 sublingual tablets in 1 carton)
- Official record key
drug-enforcement:D-1278-2015
Official wording
Reason: Failed dissolution specifications
Code information: Lot # 3122833A, Expiry 5/31/16
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
Failed dissolution specifications