Mylan Recalls Doxorubicin Vials Due to Potential Mispackaging
Mylan Institutional LLC is recalling 936 vials of Doxorubicin Hydrochloride Injection because they may have been mispackaged with Ifosfamide Injection.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Mylan Institutional LLC is recalling 936 vials of Doxorubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL). The recall is due to a mispackaging error where correctly labeled vials of Ifosfamide Injection 50 mg/mL, 60 mL may have been packaged in cartons labeled for Doxorubicin Hydrochloride Injection.
The affected product is identified by Lot Number 7801009 and has an expiration date of April 2015. The product was distributed nationwide. The recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Healthcare providers and patients should check their inventory for this specific lot number and contact Mylan Institutional LLC for further instructions on how to return the product.
The recalled product
- Product
- DOXOrubicin Hydrochloride Injection, USP, 200 mg/100 mL (2 mg/mL), For IV Use Only, Sterile, ISOTONIC SOLUTION, Caution: Cytotoxic Agent, 100 mL Multi-Dose Vial, Rx Only, Manufactured By: Onco Therapies Limited, Bangalore, 560105, INDIA, Distributed By: Amneal-Agila, LLC…
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Injection
- Affected units
- 936
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 Number: 7801009
- Exp: Apr-2015
Distribution
Distributed nationwide across the United States.
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