Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industri
Summary
The FDA issued a Class II for Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Dis by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment..
Details
Source
Drug Recall
External ID
D-0269-2024
Action Date
2024-01-31
Status
Completed
Category
drug
Product Description
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.
Lot/Code Info: Lot #: DNE0788A Exp. 07/31/2025
Quantity Affected: 6552 bottles
Reason for Recall
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-01-18
Company
Princeton, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 60 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 clearance.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (SUN PHARMACEUTICAL INDUSTRIES INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does SUN PHARMACEUTICAL INDUSTRIES INC have FDA actions?
SUN PHARMACEUTICAL INDUSTRIES INC has 84 FDA actions in our database, including 83 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0269-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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