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Chemotherapy Agent Recalled


July 13, 2018

Ingenus Pharmaceuticals is recalling nearly 50,000 vials of irinotecan hydrochloride injection because they may be superpotent, according to the July 11, 2018, US Food and Drug Administration (FDA) Enforcement Report.

The recall includes the following products, which were distributed across the United States:

  • irinotecan hydrochloride injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2-mL single-dose vial (NDC 50742-401-02), from lots 17034-2, 17035-2, and 17036-2 (Exp. 8/19); and
  • irinotecan hydrochloride injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5-mL single-dose vial (NDC 50742-402-05), from lots 17034-1, 17035-1, and 17036-1 (Exp. 8/19).

Ingenus Pharmaceuticals voluntarily initiated the recall June 8, 2018. On June 29, 2018, the FDA designated the recall Class II. The classification communicates use of the affected product could cause temporary or medically reversable harm. Serious adverse effects are possible, although the likelihood is remote.

Irinotecan hydrochloride injection is a prescription medication used in the treatment of patients with metastatic carcinoma of the colon or rectum.

Jolynn Tumolo


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