Reported Jan 31, 2024 · Completed
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical…
Sun Pharmaceutical Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle
- Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
- Manufactured by
Sun Pharmaceutical Industries LimitedSurvey No. 259/15Dadra-396 191(U.T. of D & NH)INDIANDC 47335-613-81
- Lot codes and dates
- Lot #: DNE0788A Exp. 07/31/2025
- Amount recalled
- 6552 bottles
This recall covers 11 products
The agency filed one notice per product. You are reading one of them; the other 10 are below.
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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