FDA Drug recall D-1332-2015
Gemcitabine for Injection, USP, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Insti…
- 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, 200 mg*/vial, Lyophilized powder in a Single-Use Vial, Rx only, labeled as a) Manufactured for: Mylan Insti… by Mylan Institutional, citing presence of Particulate Matter.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1332-2015 |
| 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, 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
Presence of Particulate Matter
Identifiers
| upc | 367457464206 |
|---|---|
| upc | 300693857104 |
| code_info | Lot #: a) 7801396, 7801398, 7801401, 7801406, Exp 08/16; 7801427, Exp 09/16; b) 7801089, 7801084, Exp 07/15; 7801110, Exp 08/15 |
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-1332-2015%22
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