Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
ZOLPIDEM TARTRATE SUBLINGUAL TABLET 3.5 MG 30 UNIT DOSE POUCHES; NDC/UPC 49884089911; RX; EACH POUCH CONTAINS ONE SUBLINGUAL TABLET
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.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Reason Failed Dissolution Specifications
Reason Failed dissolution specifications
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
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