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
Is Eszopiclone recalled?
4 FDA recalls mention Eszopiclone. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Eszopiclone.
Class II · Moderate risk Terminated
Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro…
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; 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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