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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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.
- Category
- Drug — Prescription Medication
- Hazard
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
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