Drug Enforcement D-0581-2024

Failed Impurities/Degradation Specifications: Related Substances

Status

Ongoing

Classification

Class III

Report Date

July 10, 2024

Termination Date

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Product Information

Product description
Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30
Product quantity
13,752 bottles
Reason for recall
Failed Impurities/Degradation Specifications: Related Substances
Recall initiation reason
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Initial firm notification
N/A
Distribution pattern
OH, MS

Location & Firm

Recalling firm
Dr. Reddy's Laboratories, Inc.
Address
107 College Rd E, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0581-2024
Event ID
94754
Recall initiation date
June 4, 2024
Center classification date
July 2, 2024
Code info
Lot#: C2302598, Exp 2/29/2025
More code info
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