Recalls / Class II
Class IID-0359-2023
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.
- Affected lot / code info
- 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
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Nephron Sterile Compounding Center LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4500 12th Street Ext, N/A, West Columbia, South Carolina 29172-3025
Distribution
- Quantity
- 546,450 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-02-22
- FDA classified
- 2023-02-27
- Posted by FDA
- 2023-03-08
- Terminated
- 2024-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0359-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.