Injections Recalled Over Sterility Concerns

A lack of sterility assurance has prompted Nephron Sterile Compounding Center to recall more than a dozen lots of phenylephrine hydrochloride injection, according to the March 8, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following products from the Nephron 503B Outsourcing Facility in West Columbia, South Carolina, which were distributed throughout the United States:

• phenylephrine HCL injection, 0.4 mg/10 mL (40 mcg/mL), 10-mL single-dose vials, 30-vial cartons, 12 cartons per case (NDC 69374-305-10), from lot PE2028 (Exp. 6/15/23); 
• phenylephrine HCL injection, 0.8 mg/10 mL (80 mcg/mL), 10-mL single-dose vials, 30-vial cartons, 12 cartons per case (NDC 69374-301-10), from lot PE2029 (Exp. 06/17/23); 
• phenylephrine HCL injection, 1 mg/10 mL (100 mcg/mL), 10-mL single-dose vials, 30-vial cartons, 12 cartons per case (NDC 69374-302-10), from lots PE2025 (Exp. 5/28/23), PE2026 (Exp. 6/2/23), PE2027 (Exp. 6/4/23), PE2030 (Exp. 6/29/23), PE2031 (Exp. 6/27/23), PE2032 (Exp. 7/9/23), PE2032A (Exp. 7/9/23), PE2033 (Exp. 8/3/23), PE2034 (Exp. 8/31/23), and PE2035 (Exp. 9/11/23); and 
• phenylephrine HCL in 0.9% sodium chloride injection, 50 mg/250 mL (200 mcg/mL), 250-mL single-dose container bottles, 15 bottles per carton (NDC 69374-321-25), from lot PS2008A (Exp. 3/7/23).

Nephron Sterile Compounding Center voluntarily initiated the recall February 22, 2023. The FDA designated the recall Class II on February 27, 2023. Products affected by Class II recalls may cause temporary or medically reversible adverse health consequences if used. While remote, a possibility of serious harm also exists.

Phenylephrine hydrochloride injection is used to raise blood pressure in patients with clinically important hypotension.