Drug recall D-0578-2022
Product
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
Lots and codes
Lot #: P0602, Exp. Date 03/2023
Recall details
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ
- Quantity
- 59,232 bottles
- Distribution
- Nationwide with the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- February 7, 2022
- Terminated
- July 17, 2023
Related products
- Chlorthalidone – drug information
- NDC 57664-649 Chlorthalidone · Chlorthalidone 50 mg/1 · Sun Pharmaceutical Industries, Inc.
- NDC 57664-648 Chlorthalidone · Chlorthalidone 25 mg/1 · Sun Pharmaceutical Industries, Inc.