Recalls / Class II
Class IID-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.
- Brand name
- Chlorthalidone
- Generic name
- Chlorthalidone
- Active ingredient
- Chlorthalidone
- Route
- Oral
- NDCs
- 57664-648, 57664-649
- FDA application
- ANDA089286
- Affected lot / code info
- Lot #: P0602, Exp. Date 03/2023
Why it was recalled
Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
Recalling firm
- Firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Independence Way, N/A, Princeton, New Jersey 08540-6620
Distribution
- Quantity
- 59,232 bottles
- Distribution pattern
- Nationwide with the United States
Timeline
- Recall initiated
- 2022-02-07
- FDA classified
- 2022-02-23
- Posted by FDA
- 2022-02-23
- Terminated
- 2023-07-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0578-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.