FDA recall D-0578-2022

SUN PHARMACEUTICAL INDUSTRIES INC · Class II · drug

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

Distribution

Nationwide with the United States

Key facts

Status
Terminated
Initiation date
2022-02-07
Report date
2022-02-23
Termination date
2023-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Princeton, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0578-2022