D-0578-2022 Class II Terminated
FDA drug recall D-0578-2022 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on Feb 7, 2022 and is designated Class II. Reason for recall: Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup The recall status is terminated (terminated Jul 17, 2023). Affected quantity: 59,232 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 23, 2022
- Initiation Date
- Feb 7, 2022
- Termination Date
- Jul 17, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 59,232 bottles
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.
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 Pattern
Nationwide with the United States
Code Information
Lot #: P0602, Exp. Date 03/2023
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0578-2022
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026