Recalls / Class II
Class IID-0207-2021
Product
Sodium Citrate 4% 3 mL Anticoagulation Solution (40mg/mL), Rx only, 3 mL Single Dose Syringe, SCA Pharmaceuticals, 755 Rainbow Rd., Windsor, CT, 06095, barcode 70004090025
- Affected lot / code info
- Lot # 1220022961, BUD 1/20/2021; 1220023121, BUD 1/25/2021; 1220023207, BUD 2/12/2021; 1220023363, BUD 2/17/2021 & 1220023526, BUD 2/23/2021.
Why it was recalled
Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Recalling firm
- Firm
- SCA Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 755 Rainbow Rd Ste B, Windsor, Connecticut 06095-1024
Distribution
- Quantity
- 5,990 syringes
- Distribution pattern
- Product was distributed to hospitals nationwide.
Timeline
- Recall initiated
- 2020-12-17
- FDA classified
- 2021-01-07
- Posted by FDA
- 2021-01-13
- Terminated
- 2021-11-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0207-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.