RecallRadar

FDA Drug recall D-0422-2024

Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainb…

On 2024-04-03 the FDA classified a Class II recall of Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 40/mg/mL) 3mL fill Syringe, Repackaged by SCA Pharma, 755 Rainb… by Sca Pharmaceuticals, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0422-2024
ClassificationClass II
Statusterminated
Initiated2023-11-09
Published2024-04-03
Last updated2026-09-13 11:52 UTC
CompanySca Pharmaceuticals
DistributionUS

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

Reason

Lack of Assurance of Sterility

Identifiers

code_infoLot #: 1223048444 Exp 11/20/23; 1223049011 Exp 12/12/23; 1223049673 Exp 01/09/24; 1223049771 Exp 01/12/24

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0422-2024%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.