Mylan Recalls Gemcitabine Injection Vials Due to Particulate Matter
Mylan Institutional LLC is recalling 2,455 vials of Gemcitabine for Injection due to the presence of particulate matter.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which meets the criteria for a Critical severity score.
Plain-English summary
Mylan Institutional LLC is recalling 2,455 vials of Gemcitabine for Injection, USP, 2 g/vial. The product is a lyophilized powder in a single-use vial, prescription only, and was manufactured in India. The recall is being conducted because of the presence of particulate matter in the product.
The affected product is identified by NDC 67457-463-02 and UPC 3 67457 46302 5. The specific lots involved are 7801221 and 7801222, with an expiration date of 03/16. The product was distributed nationwide and in Puerto Rico.
This recall is classified as Class I by the FDA. Healthcare providers and patients should stop using the affected vials and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-463-02, UPC 3 67457 46302 5.
- Manufacturer
- Mylan Institutional LLC
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 2,455
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 (3)
- Lot #: 7801221
- 7801222
- Exp 03/16
Distribution
Part of a larger recall action
This product is one of 3 recalled by Mylan Institutional LLC 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.
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