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
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: P0602, Exp. Date 03/2023
Where it was sold
Nationwide with the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0578-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 7, 2022
- FDA report date
- Feb 23, 2022
- Quantity
- 59,232 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
Original FDA data
Every field from FDA enforcement report D-0578-2022, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89529
- Address
- 2 Independence Way
- Code information
- Lot #: P0602, Exp. Date 03/2023
- Postal code
- 08540-6620
- Report date
- Feb 23, 2022
- Product type
- Drugs
- Recall number
- D-0578-2022
- Classification
- Class II
- Recalling firm
- SUN PHARMACEUTICAL INDUSTRIES INC
- Product quantity
- 59,232 bottles
- Termination date
- Jul 17, 2023
- Reason for recall
- Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubricant oil and silicone particles from the dust cup
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide with the United States
- Recall initiation date
- Feb 7, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 23, 2022