FDAClass IIAugust 28, 2013

Irinotecan Hydrochloride Injection recall

IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL…

Why was Irinotecan Hydrochloride Injection recalled?

Crystallization: Active pharmaceutical ingredient is precipitating in product solution.

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 #: 872CZ00101, Exp 12/13

Product
IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL…
Recalling firm
Fresenius Kabi USA LLC (FK USA)
Quantity
23,672 vials
Distribution
Nationwide
Recall date
August 28, 2013
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls