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.
FDA recall notice · announced April 13, 2016 · 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 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
Reason for recall
Failed Dissolution Specifications
Notes
Distribution: U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.
Lot/code information: Lot #: 3126431B, Expiry: 09/30/17
Quantity: 2172 Cartons
Status: Terminated
Products in this recall event:
- 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)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.