Drug Recall: 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 Lim
SUN PHARMACEUTICAL INDUSTRIES INC · January 18, 2024
Reason for Recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
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.
Distribution
Nationwide in the USA
States Affected
NATIONWIDE
Quantity Affected
6552 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0269-2024
Status: completed
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