Multi-event June 2020 FDA Recall Irinotecan Hydrochloride by Hikma Pharmaceuticals Usa Inc.
This Multi-event Class II drug recall was voluntarily initiated by Hikma Pharmaceuticals Usa Inc. on June 11, 2020 for the product Irinotecan Hydrochloride. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1309-2020
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
06-11-2020
06-24-2020
17,998 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.
Hikma Pharmaceuticals USA Inc.
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 within the United States
06-10-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9583-01
Batch or Lot Expiration Information
Lot# :AC0231A, exp. date 08/2021
Affected Packages Involved in this Recall
Recall Number: D-1308-2020
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
06-11-2020
06-24-2020
82,426 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.
Hikma Pharmaceuticals USA Inc.
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 within the United States
06-10-2021
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Irinotecan HCL Injection, USP, 100mg/5mL, 5 mL vials, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA, NDC 0143-9701-01
Batch or Lot Expiration Information
Lot# : AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021
