FDAClass IIIJuly 29, 2015

Intermezzo recall: Failed Dissolution

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

Why was Intermezzo recalled?

Failed dissolution specifications

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot # 3122833A, Expiry 5/31/16

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
Recalling firm
Purdue Pharma L.P.
Quantity
6,264 cartons (30 sublingual tablets in 1 carton)
Distribution
Nationwide and Puerto Rico
Recall date
July 29, 2015
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls