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.
D-0578-2022
Product summary
- Event
- Event 89529
- Status
- Terminated
- Classification
- Class II
- Quantity
- 59,232 bottles
- Official record key
drug-enforcement:D-0578-2022
Official wording
Reason: Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Code information: Lot #: P0602, Exp. Date 03/2023
Distribution pattern: Nationwide with the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Matter