FDA-Drug2024-01-31Class II
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.
SUN PHARMACEUTICAL INDUSTRIES INC
Hazard
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Sold states
Nationwide in the USA
Affected count
15,768 bottles
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0270-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief