Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.
Reported: August 26, 2015 Initiated: March 23, 2015 #D-1332-2015
Product Description
Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.
Reason for Recall
Presence of Particulate Matter
Details
- Recalling Firm
- Mylan Institutional LLC
- Units Affected
- a) 35,197 vials; b) 21,302 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Rockford, IL
Frequently Asked Questions
What product was recalled? ▼
Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Institutional LLC, Rockford, IL 61103, Made in India, NDC 67457-464-20, UPC 3 67457 46420 6; and b) Distributed by Pfizer Labs, Division of Pfizer Inc, New York, NY 10017, Made in India, NDC 0069-3857-10, UPC 3 00693 85710 4.. Recalled by Mylan Institutional LLC. Units affected: a) 35,197 vials; b) 21,302 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-1332-2015.
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