FDA Drug recall D-1334-2015
Gemcitabine for Injection, USP, 1 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, 1 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-1334-2015 |
| 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, 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
Presence of Particulate Matter
Identifiers
| upc | 367457462011 |
|---|---|
| code_info | Lot #: 7801273, 7801284, Exp 05/16 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Other recalls by Mylan Institutional
- Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton,…
FDA Drug · Class II · 2025-03-26 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton,…
FDA Drug · Class II · 2025-03-26 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manuf…
FDA Drug · Class II · 2024-12-18 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
FDA Drug · Class II · 2024-12-18 · Mylan Institutional - Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Man…
FDA Drug · Class II · 2024-12-18 · Mylan Institutional
All Mylan Institutional recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1334-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.