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
Reported: July 29, 2015 Initiated: July 13, 2015 #D-1278-2015
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
Details
- Recalling Firm
- Purdue Pharma L.P.
- Units Affected
- 6,264 cartons (30 sublingual tablets in 1 carton)
- Distribution
- Nationwide and Puerto Rico
- Location
- Stamford, CT
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Purdue Pharma L.P.. Units affected: 6,264 cartons (30 sublingual tablets in 1 carton).
Why was this product recalled? ▼
Failed dissolution specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on July 29, 2015. Severity: Low. Recall number: D-1278-2015.
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