Reported Jul 11, 2018 · Terminated
Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for:…
Ingenus Pharmaceuticals LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ingenus Pharmaceuticals Llc · 4190 Millenia Blvd · Orlando, FL · 32839-6408
Is this the product you have?
- Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only
- Manufactured forIngenius Pharmaceuticals, LLC, Orlando, FL 32839-6408
- Manufactured byIngenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05
- Lot codes and dates
Lot #: 17034-117035-117036-1Exp. 08/19
- Amount recalled
- 34964 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Superpotent Drug: High out of specification assay value results for potency.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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