Drug recall D-0269-2024
Product
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.
Reason for recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Lots and codes
Lot #: DNE0788A Exp. 07/31/2025
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 6552 bottles
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 18, 2024
Related products
- Niacin – drug information
- NDC 47335-614 Niacin · Niacin 750 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-613 Niacin · Niacin 1000 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 47335-539 Niacin · Niacin 500 mg/1 · Sun Pharmaceutical Industries, Inc.