Hikma Recalls Irinotecan Hydrochloride Vials Due to Container Defect
Hikma Pharmaceuticals is recalling 17,998 vials of Irinotecan Hydrochloride Injection due to a crimp defect in the flip-cap.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a moderate severity score under the rubric for minor labeling or packaging errors without reported serious injury.
Plain-English summary
Hikma Pharmaceuticals USA Inc. is recalling 17,998 vials of Irinotecan Hydrochloride Injection, USP, 100mg/5mL. The affected product is identified by Lot #AC0231A with an expiration date of 08/2021. The vials were distributed nationwide within the United States.
The recall was initiated due to customer complaints regarding a crimp defect observed while removing the flip-cap during use. This defect is classified as a defective container issue.
Healthcare providers and patients should stop using the affected vials and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- IRINOTECAN HYDROCHLORIDE (IRINOTECAN HYDROCHLORIDE)
- Brand
- IRINOTECAN HYDROCHLORIDE
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 17,998
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #:AC0231A
- exp. date 08/2021
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Hikma Pharmaceuticals USA Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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