FDA Recalls Sodium Citrate Injectable Solution Due to Sterility Concerns
SCA Pharmaceuticals recalls Sodium Citrate 4% injectable solution syringes (9,624 units) distributed nationwide due to lack of assurance of sterility.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of injectable medication due to lack of assurance of sterility. While no illnesses or hospitalizations have been reported, sterility failure in injectable products represents a significant risk-of-harm scenario that could lead to serious infections.
Plain-English summary
SCA Pharmaceuticals, LLC is recalling Sodium Citrate 4% 3 mL Anticoagulation Solution Injection syringes due to lack of assurance of sterility. The recall affects 9,624 syringes with the following lot numbers: 1223048444 (Exp 11/20/23), 1223049011 (Exp 12/12/23), 1223049673 (Exp 01/09/24), and 1223049771 (Exp 01/12/24).
The product was distributed nationwide in the United States. Sodium Citrate is used as an anticoagulation solution in medical settings. Injectable medications require strict sterility standards to prevent contamination and infection.
Patients and healthcare providers who have the recalled product should contact their healthcare provider or SCA Pharmaceuticals for further guidance. Do not use the recalled syringes.
The recalled product
- 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
- Manufacturer
- SCA Pharmaceuticals, LLC
- Hazard
- sterility-failure
- infection-risk
- contamination-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 1223048444 Exp 11/20/23
- 1223049011 Exp 12/12/23
- 1223049673 Exp 01/09/24
- 1223049771 Exp 01/12/24
Distribution
Distributed nationwide across the United States.
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