Drug Enforcement D-0271-2024

CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.

Status

Completed

Classification

Class II

Report Date

January 31, 2024

Termination Date

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Product Information

Product description
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.
Product quantity
1220 bottles
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
SUN PHARMACEUTICAL INDUSTRIES INC
Address
2 Independence Way, N/A

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

Recall number
D-0271-2024
Event ID
93820
Recall initiation date
January 18, 2024
Center classification date
January 25, 2024
Code info
Lot #: DNE0892A Exp. 07/31/2026
More code info
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