The Recall Desk
LowFDA (Drugs)·D-1278-2015·Announced 2015-07-29

Purdue Pharma Recalls Intermezzo Sublingual Tablets for Dissolution Failures

Purdue Pharma is recalling Intermezzo (zolpidem tartrate) sublingual tablets because they failed to meet dissolution specifications.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the source text does not report any injuries or illnesses.

Plain-English summary

Purdue Pharma L.P. is recalling Intermezzo (zolpidem tartrate) sublingual tablets, 3.5 mg, 1 tablet per pouch, 30 pouches per carton. The recall involves 6,264 cartons of the product, identified by Lot # 3122833A with an expiration date of 5/31/16.

The recall was initiated because the affected tablets failed to meet dissolution specifications. This means the tablets may not dissolve in the mouth as intended, potentially affecting the delivery of the medication.

The affected product was distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot number and expiration date listed above. If the product is found, it should be returned to the pharmacy or point of purchase for a refund or replacement.

The recalled product

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
Manufacturer
Purdue Pharma L.P.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot # 3122833A
  • Expiry 5/31/16

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Purdue Pharma L.P.

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