Fresenius Kabi Recalls Irinotecan Hydrochloride Injection Due to Crystallization
Fresenius Kabi USA LLC is recalling 23,672 vials of Irinotecan Hydrochloride Injection because the active ingredient is precipitating in the solution.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage risks, or high-risk scenarios without reported fatalities.
Plain-English summary
Fresenius Kabi USA LLC (FK USA) is recalling 23,672 vials of Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial. The product is manufactured for APP Pharmaceuticals, LLC, and is identified by NDC 63323-193-02 and UPC 3 63323 19302 7. The specific lot affected is 872CZ00101, with an expiration date of 12/13.
The recall was initiated because the active pharmaceutical ingredient is precipitating in the product solution, a condition described as crystallization. This defect affects the physical stability of the medication.
The affected vials were distributed nationwide. Healthcare providers and patients should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- 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.
- Manufacturer
- Fresenius Kabi USA LLC (FK USA)
- Category
- Drug — Injectable Medication
- Affected units
- 23,672
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 #: 872CZ00101
- Exp 12/13
Distribution
Distributed nationwide across the United States.
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