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Class II · ModerateRecall completed

Irinotecan Hydrochloride

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byThymoorgan Pharmazie GmbH, Shiffgraben 23, 38690 Golsar, Germany Distributed by: West-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA foreign manufacturer
Brand nameIRINOTECAN HYDROCHLORIDE
Generic nameIRINOTECAN HYDROCHLORIDE
Active ingredient(s)IRINOTECAN HYDROCHLORIDE
Distributed by / forWest-Word Pharmaceutical Corp. Eatontown, NJ 07724 USA
NDC0143-9701-01
Show the full FDA record
Full product labelIrinotecan 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
Recalling firmHikma Pharmaceuticals USA Inc.
DistributionNationwide within the United States
Quantity82,426 vials
Recall initiated2020-06-11
Report date2020-06-24
Recall completed2021-06-10
Recall numberD-1308-2020
ClassificationClass II
FDA statusTerminated
Origin on fileCherry Hill NJ United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.