Drug Released Without Approval Recalled

The Ritedose Corporation is recalling 44 cartons of cromolyn sodium oral solution (concentrate) that was released without supplier approval, according to the August 9, 2023, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects cromolyn sodium oral solution (concentrate), 100 mg/5 mL, 96 plastic ampules per carton (NDC 76204-025-96), from lot 23CE2 (Exp 3/31/26). The product was manufactured by the Ritedose Corporation, Columbia, South Carolina, for Ritedose Pharmaceuticals, Columbia, South Carolina, and was distributed throughout the United States.

The Ritedose Corporation voluntarily initiated the recall July 21, 2023. On July 31, 2023, the FDA designated it Class II, communicating that use of the affected product could cause temporary or medically reversible adverse health consequences, or a remote possibility of serious harm.

Cromolyn sodium oral solution (concentrate) is a prescription medication indicated in the management of patients with mastocytosis.