Drug recall D-0891-2018
Product
Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.
Reason for recall
Superpotent Drug: High out of specification assay value results for potency.
Lots and codes
Lot #: 17034-2, 17035-2, 17036-2; Exp. 08/19
Recall details
- Recalling firm
- Ingenus Pharmaceuticals Llc, Orlando, FL
- Quantity
- 14089 vials
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- June 8, 2018
- Terminated
- May 1, 2019
Related products
- Irinotecan Hydrochloride – drug information
- NDC 50742-401 Irinotecan Hydrochloride · Irinotecan Hydrochloride 40 mg/2mL · Ingenus Pharmaceuticals, LLC
- NDC 50742-402 Irinotecan Hydrochloride · Irinotecan Hydrochloride 100 mg/5mL · Ingenus Pharmaceuticals, LLC