FDA Drug recall D-1333-2015
Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Roc…
- FDA Drug
- Class I
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class I recall of Gemcitabine for Injection, USP, 2 g*/vial, Lyophilized powder in a Single-Use Vial, Rx only, Manufactured for: Mylan Institutional LLC, Roc… by Mylan Institutional, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1333-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-03-23 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Mylan Institutional |
| Distribution | US |
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.
Reason
Presence of Particulate Matter
Identifiers
| upc | 367457463025 |
|---|---|
| code_info | Lot #: 7801221, 7801222, Exp 03/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1333-2015%22
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