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Recall Observatory FDA recall evidence

Drug 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

D-1280-2022

June 30, 2022

Class II

Product summary

Firm
Nephron Sterile Compounding Center LLC
Event
Event 90512
Status
Terminated
Classification
Class II
Quantity
85,300 syringes
Official record key
drug-enforcement:D-1280-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: 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

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility