Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
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
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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.
Affected NDC
59011-0256-30
Compare with the code on your package — it is the most precise check available.
Drug: Zolpidem
- Recalling firm
- Purdue Pharma L.P.
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0810-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Zolpidem recalls
See all
Class II · Moderate risk
Zolpidem Tartrate Extended-Release Tablets
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk
Zolpidem Tartrate Sublingual Tablet 3.5 Mg 30 Unit Dose Pouches
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Intermezzo
Failed dissolution specifications
Class II · Moderate risk
Zolpidem Tartrate Tablets
CGMP Deviations: Firm did not adequately investigate customer complaints.
Other recalls by Purdue Pharma L.P.
All 2016 recalls
Class III · Low risk
Intermezzo
Failed dissolution specifications
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