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Recall Observatory FDA recall evidence

Drug product

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x 30 Vials Carton per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th St. Extension, West Columbia, SC 29172, NDC 69374-302-10.

D-0359-2023

February 22, 2023

Class II

Product summary

Firm
Nephron Sterile Compounding Center LLC
Event
Event 91749
Status
Terminated
Classification
Class II
Quantity
546,450 vials
Official record key
drug-enforcement:D-0359-2023

Official wording

Reason: Lack of Assurance of Sterility

Code information: Lots: PE2025, Exp. 05/28/2023; PE2026, Exp. 06/02/2023; PE2027, Exp. 06/04/2023; PE2030, Exp. 06/29/2023; PE2031, Exp. 06/27/2023; PE2032, Exp. 07/09/2023; PE2032A, Exp. 07/09/2023; PE2033, Exp. 08/03/2023; PE2034, Exp. 08/31/2023; PE2035, Exp. 09/11/2023

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    Lack of Assurance of Sterility