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.

FDA recall notice · announced February 23, 2022 · Sun Pharmaceutical Industries

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Notes

Distribution: Nationwide with the United States
Lot/code information: Lot #: P0602, Exp. Date 03/2023
Quantity: 59,232 bottles
Status: Terminated
Products in this recall event:
- 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, N (D-0578-2022)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.