Reported Jul 29, 2015 · Terminated

Intermezzo (zolpidem tartrate), sublingual tablet 3.5 mg, 1 tablet per pouch, 30 pouches per carton, Rx only,…

Purdue Pharma LP

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Purdue Pharma L.P. · 201 Tresser Blvd · Stamford, CT · 06901-3435

Is this the product you have?

    • 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
Lot codes and dates
    • Lot # 3122833A
    • Expiry 5/31/16
Amount recalled
6,264 cartons (30 sublingual tablets in 1 carton)

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed dissolution specifications

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 15, 2017 · Data as of Sep 19, 7:22 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.