Reported Mar 8, 2023 · Terminated
Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile…
Nephron Sterile Compounding Center LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Nephron Sterile Compounding Center LLC · 4500 12th Street Ext · West Columbia, SC · 29172-3025
Is this the product you have?
- 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.
- Lot codes and dates
10 of 10 products
Products covered by this recall # Product as published 1 PE2025, Exp. 05/28/2023 2 PE2026, Exp. 06/02/2023 3 PE2027, Exp. 06/04/2023 4 PE2030, Exp. 06/29/2023 5 PE2031, Exp. 06/27/2023 6 PE2032, Exp. 07/09/2023 7 PE2032A, Exp. 07/09/2023 8 PE2033, Exp. 08/03/2023 9 PE2034, Exp. 08/31/2023 10 PE2035, Exp. 09/11/2023 - Amount recalled
- 546,450 vials
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
- Nationwide
Why it was recalled
Lack of Assurance of Sterility
This product could cause temporary or reversible health problems — stop using it.
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