Class III · Low risk Ongoing
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090…
Reason Failed Impurities/Degradation Specifications: Related Substances
Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
What was recalled
Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, NDC 33342-299-07
- Recalling firm
- Macleods Pharma Usa Inc
- NDC code
- 33342-299-07
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1174-2022
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 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk Terminated
ESZOPICLONE, Tablet, 3 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63402019310
Reason Labeling:Label Mixup; ESZOPICLONE, Tablet, 3 mg may be potentially mislabeled as CHOLECALCIFEROL, Tablet, 1000 units, NDC 00904582460, Pedigree…
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