RecallRadar

FDA Drug recall D-1280-2022

Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 S…

On 2022-07-27 the FDA classified a Class II recall of Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 S… by Nephron Sterile Compounding Center, citing lack of Assurance of Sterility.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-1280-2022
ClassificationClass II
Statusterminated
Initiated2022-06-30
Published2022-07-27
Last updated2026-09-13 11:52 UTC
CompanyNephron Sterile Compounding Center
DistributionUS

Product

Anticoagulant Sodium Citrate Solution, USP 4%, 200 mg/5 mL (40 mg/mL) syringe, packaged in 5 x 5 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per case, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-906-05

Reason

Lack of Assurance of Sterility

Identifiers

code_info
Lots: SC2002A, Exp. 7/9/2022; SC2004A, Exp. 7/17/2022; SC2005A, Exp. 8/2/2022; SC2006A, Exp. 8/16/2022; SC2007A, Exp. 8…Lots: SC2002A, Exp. 7/9/2022; SC2004A, Exp. 7/17/2022; SC2005A, Exp. 8/2/2022; SC2006A, Exp. 8/16/2022; SC2007A, Exp. 8/27/2022; SC2008A, Exp. 9/7/2022; SC2009A, Exp. 9/14/2022; SC2010A, Exp. 9/20/2022; SC2011A, Exp. 10/10/2022

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-1280-2022%22

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