More than 30 Injection Products Recalled for Sterility Concerns

SCA Pharmaceuticals is recalling 32 injection drug products in bags, syringes, and cassettes due to a lack of assurance of sterility, according to the April 3, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes various formulations containing diltiazem, fentanyl, hydromorphone, labetalol, midazolam, neostigmine methylsulfate, phenylephrine, sodium citrate, succinylcholine, and vancomycin. The products were distributed throughout the United States.

SCA Pharmaceuticals voluntarily initiated the recalls November 9, 2023. The FDA designated them Class II on March 22, 2024. Per the classification, use of the recalled products may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

The FDA Enforcement Report includes the comprehensive list of recalled products and their associated lot numbers.