Drug product

Niacin Extended-Release Tablets, USP 500mg, 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 47335-539-81.

D-0270-2024

January 18, 2024

Class II

Product summary

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

Code information: Lot #s: DNE0771A Exp. 06/30/2025; DNE0857A, DNE0959A Exp. 07/31/2025.

Distribution pattern: Nationwide in the USA

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0

Microbial contamination