Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St.
Summary
The FDA issued a Class II for Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fo by SUN PHARMACEUTICAL INDUSTRIES INC. Reason: Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup.
Details
Source
Drug Recall
External ID
D-0578-2022
Action Date
2022-02-23
Status
Terminated
Category
drug
Product Description
Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: Fontida Bio Pharm Inc., 1100 Orthodox St. Philadephia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-648-88.
Lot/Code Info: Lot #: P0602, Exp. Date 03/2023
Quantity Affected: 59,232 bottles
Reason for Recall
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Distribution
Nationwide with the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2022-02-07
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-0578-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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