D-1333-2015 Class I Terminated
FDA drug recall D-1333-2015 was initiated by Mylan Institutional LLC on Mar 23, 2015 and is designated Class I. Reason for recall: Presence of Particulate Matter The recall status is terminated (terminated May 20, 2016). Affected quantity: 2,455 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 26, 2015
- Initiation Date
- Mar 23, 2015
- Termination Date
- May 20, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,455 vials
Product Description
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.
Reason for Recall
Presence of Particulate Matter
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot #: 7801221, 7801222, Exp 03/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1333-2015
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026