Gemcitabine for Injection — Class I drug recall D-1333-2015
Terminated recall by Mylan Institutional LLC, reported 2015-08-26, distributed nationwide. Presence of Particulate Matter
| Recall number | D-1333-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mylan Institutional LLC, Rockford, IL, United States |
| Recall initiated | 2015-03-23 |
| Classified | 2015-08-14 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-05-20 |
| Distributed | Nationwide (US) |
| Quantity | 2,455 vials |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00367457463025 |
| NDC | 67457-0463-02 |
| Lot numbers | 03/16, 7801221, 7801222 |
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 for recall
Presence of Particulate Matter
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1333-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.