Home / Recalls / Purdue Pharma L.P. / D-1278-2015

D-1278-2015 Class III Terminated

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

Recall Details

Product Type: Drugs
Report Date: July 29, 2015
Initiation Date: July 13, 2015
Termination Date: May 15, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 6,264 cartons (30 sublingual tablets in 1 carton)

Product Description

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

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot # 3122833A, Expiry 5/31/16