Class III · Low risk Ongoing
Eszopiclone Tablets
Reason Failed Impurities/Degradation Specifications: Related Substances
Eszopiclone
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree: W002779, EXP: 6/6/2014.
What was recalled
ESZOPICLONE, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402019310
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-680-2014
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 Eszopiclone recalls
See all
Class II · Moderate risk Terminated
Eszopiclone Tablets
Reason Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
Class II · Moderate risk Terminated
Eszopiclone 3mg 100 C4
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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