January 2013 FDA Recall Drug by Fresenius Kabi Usa Llc (fk Usa) (D-915-2013 - Crystallization)
This Class II drug recall was voluntarily initiated by Fresenius Kabi Usa Llc (fk Usa) on January 22, 2013 for the product Drug. The FDA reported the reason for recall as crystallization. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-915-2013
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
01-22-2013
08-28-2013
23,672 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA LLC (FK USA)
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
05-12-2015
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
Batch or Lot Expiration Information
Lot# : 872CZ00101, Exp 12/13
