Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.
Reported: August 26, 2015 Initiated: March 23, 2015 #D-1334-2015
Product Description
Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.
Reason for Recall
Presence of Particulate Matter
Details
- Recalling Firm
- Mylan Institutional LLC
- Units Affected
- 10,094 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
Gemcitabine for Injection, USP, 1 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-462-01, UPC 3 67457 46201 1.. Recalled by Mylan Institutional LLC. Units affected: 10,094 vials.
Why was this product recalled? ▼
Presence of Particulate Matter
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 26, 2015. Severity: Critical. Recall number: D-1334-2015.
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