Class II · Moderate risk Completed
Zolpidem Tartrate Extended-Release Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Intermezzo
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Dissolution Specifications
What was recalled
Intermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
- Recalling firm
- Purdue Pharma L.P.
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0810-2016
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Zolpidem recalls
See all
Class II · Moderate risk Completed
Zolpidem Tartrate Extended-Release Tablets
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Terminated
Zolpidem Tartrate Sublingual Tablet 3.5 Mg 30 Unit Dose Pouches
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Intermezzo
Reason Failed dissolution specifications
Class II · Moderate risk Terminated
Zolpidem Tartrate Tablets
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
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