Fresenius Kabi Recalls Doxorubicin Hydrochloride Injection Due to Cross-Contamination
Fresenius Kabi is recalling Doxorubicin Hydrochloride Injection vials because testing found trace amounts of octreotide.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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 III, which indicates the product is not likely to cause adverse health consequences. The hazard involves trace cross-contamination with octreotide, which is a low-risk contamination issue without reported injuries.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 16,986 vials of Doxorubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL). The affected product is a single-dose vial, prescription only, sterile, manufactured in Lake Zurich, IL. The specific batch involved is 6120525, with an expiration date of 11/2020.
The recall was initiated because testing revealed trace amounts of octreotide in the product, indicating cross-contamination with other products. Doxorubicin Hydrochloride is an intravenous prescription drug used for cancer treatment.
The affected vials were distributed nationwide in the United States and Puerto Rico. Healthcare providers and patients should stop using the affected product and contact Fresenius Kabi USA, LLC for further instructions or a replacement.
The recalled product
- Product
- DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE)
- Brand
- DOXORUBICIN HYDROCHLORIDE
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Antineoplastic
- Affected units
- 16,986
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)
- Batch: 6120525
- exp 11/2020
Distribution
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