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Recall Observatory FDA recall evidence

Drug product

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC: 69374-957-10

D-0967-2022

May 18, 2022

Class II

Product summary

Firm
Nephron Sterile Compounding Center LLC
Event
Event 90211
Status
Terminated
Classification
Class II
Quantity
585660 syringes
Official record key
drug-enforcement:D-0967-2022

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: PE1115B, PE1115C, Exp. 5/31/2022; PE1122A, Exp. 6/19/2022; PE2004B, PE2004C, Exp. 7/11/2022; PE2011A, PE2011C, Exp. 8/22/2022; PE2015A, PE2015B, PE2015C, Exp. 9/5/2022; PE2016A, PE2016B, PE2016C, Exp. 9/13/2022

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility