Recalls / Class II
Class IID-0890-2018
Product
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.
- Brand name
- Irinotecan Hydrochloride
- Generic name
- Irinotecan Hydrochloride
- Active ingredient
- Irinotecan Hydrochloride
- Route
- Intravenous
- NDCs
- 50742-401, 50742-402
- FDA application
- ANDA206935
- Affected lot / code info
- Lot #: 17034-1, 17035-1, 17036-1; Exp. 08/19
Why it was recalled
Superpotent Drug: High out of specification assay value results for potency.
Recalling firm
- Firm
- Ingenus Pharmaceuticals Llc
- Manufacturer
- Ingenus Pharmaceuticals, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4190 Millenia Blvd, Orlando, Florida 32839-6408
Distribution
- Quantity
- 34964 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-06-08
- FDA classified
- 2018-06-29
- Posted by FDA
- 2018-07-11
- Terminated
- 2019-05-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0890-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.