FDAFDA · Food and drugs·Recall number D-0890-2018
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.
Published July 11, 2018 · Recall initiated: June 8, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: High out of specification assay value results for potency.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IRINOTECAN HYDROCHLORIDE
- Manufacturer
- Ingenus Pharmaceuticals Llc
- Distributor
- Nationwide in the USA
- UPC
- 0350742402052
- Lot
- Lot #: 17034-1, 17035-1, 17036-1; Exp. 08/19
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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