Three Firms Recall Injections for Sterility Concerns

The April 10, 2024, US Food and Drug Administration (FDA) Enforcement Report included 4 drug recalls across 3 firms because of a lack of assurance of product sterility.

On February 29, 2024, SSM Health Care St. Louis, which does business as SSM St. Clare Health Center, voluntarily recalled the following products because of sterility concerns stemming from a failure to perform process validation:

• 11,798 syringes containing phenylephrine HCL 1000 mcg/10 mL, 10 mL total volume per syringe, intravenous (NDC 60652-0104-1), from lots 20240109-837CB8 (Exp. 7/7/24), 20231219-08D09D (Exp. 6/16/24), 20231121-20F8BB (Exp. 5/19/24), 20231115-2FF64D (Exp. 5/13/24), 20231101-09C52B (Exp. 4/29/24), 20231010-3D0B35 (Exp. 4/7/24), and 20230912-847E0C (Exp. 3/10/24); and
• 140 vials containing fentanyl citrate 10 mcg in 0.9% sodium chloride, 1 mL vial (10 mcg/mL), 1.5 mL total volume per vial, intravenous (NDC 60652-9010-1), from lot 20231031-0C91D9 (Exp. 2/29/24).

Both recalled products were distributed in Missouri.

On March 22, 2024, B. Braun Medical Inc. and IntegraDose Compounding Services each voluntarily recalled products for sterility concerns due to potentially leaky bags.

B. Braun Medical Inc. recalled 7800 bags of lactated Ringer's injection, 1000 mL (NDC 0264-7750-00), from lot J3N023 (Exp. 3/31/26). IntegraDose Compounding Services recalled 187 cassettes of fentanyl citrate 2500 mcg/50mL in sterile water, 50 mL CADD for injection (NDC 71139-6030-1), from lot 20231020FEN-1 (Exp. 4/17/24). Both B. Braun Medical and IntegraDose Compounding Services distributed the affected products throughout the United States.

All 4 recalls were designated Class II by the FDA in early April. Per the classification, use of the products could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.