Drug Enforcement D-0269-2024

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
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 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 47335-613-81.
Product quantity
6552 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-0269-2024
Event ID
93820
Recall initiation date
January 18, 2024
Center classification date
January 25, 2024
Code info
Lot #: DNE0788A Exp. 07/31/2025
More code info
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