FDARecalled Jan 31, 2024 · #D-0269-2024
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 ...
Hazard
Class II — temporary health risk
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CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment. Classification: Class II Distribution: Nationwide in the USA
Product details
- 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.
- Type
- Drugs
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Model numbers
- DNE0788A
- UPCs
- —