Recalls / Class II
Class IID-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.
- Brand name
- Niacin
- Generic name
- Niacin
- Active ingredient
- Niacin
- Route
- Oral
- NDCs
- 47335-539, 47335-614, 47335-613
- FDA application
- ANDA200484
- Affected lot / code info
- Lot #: DNE0788A Exp. 07/31/2025
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 6552 bottles
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-01-18
- FDA classified
- 2024-01-25
- Posted by FDA
- 2024-01-31
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0269-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.