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D-0810-2016 Class III Terminated

Recalled by Purdue Pharma L.P. — Stamford, CT

FDA drug recall D-0810-2016 was initiated by Purdue Pharma L.P. on March 31, 2016 and is designated Class III. Reason for recall: Failed Dissolution Specifications The recall status is terminated (terminated April 12, 2017). Affected quantity: 2172 Cartons.

Recall Details

Product Type: Drugs
Report Date: April 13, 2016
Initiation Date: March 31, 2016
Termination Date: April 12, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2172 Cartons

Product Description

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

Distribution Pattern

U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.

Code Information

Lot #: 3126431B, Expiry: 09/30/17