Recalls / Class II
Class IID-0422-2024
Product
Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainbow Rd., Windsor, CT 06095, NDC 70004-0900-25, Bar Code 70004090025
- Affected lot / code info
- Lot #: 1223048444 Exp 11/20/23; 1223049011 Exp 12/12/23; 1223049673 Exp 01/09/24; 1223049771 Exp 01/12/24
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- SCA Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, N/A, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 9,624 syringes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-11-09
- FDA classified
- 2024-03-22
- Posted by FDA
- 2024-04-03
- Terminated
- 2024-08-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0422-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.