Drug product
Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
D-0810-2016
Product summary
- Event
- Event 73709
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2172 Cartons
- Official record key
drug-enforcement:D-0810-2016
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: 3126431B, Expiry: 09/30/17
Distribution pattern: U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications