FDAClass IIJuly 11, 2018

Irinotecan Hydrochloride Injection recall: Superpotent

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…

Why was Irinotecan Hydrochloride Injection recalled?

Superpotent Drug: High out of specification assay value results for potency.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot #: 17034-1, 17035-1, 17036-1; Exp. 08/19

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…
Recalling firm
Ingenus Pharmaceuticals Llc
Quantity
34964 vials
Distribution
Nationwide in the USA
Recall date
July 11, 2018
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls