FDA Drug recall D-1407-2014
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmac…
- FDA Drug
- Class II
- terminated
- Published 2014-07-02
On 2014-07-02 the FDA classified a Class II recall of Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmac… by Caraco Pharmaceutical Laboratories, citing lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1407-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-09 |
| Published | 2014-07-02 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Caraco Pharmaceutical Laboratories |
| Distribution | OH |
Product
Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, Sterile Single Use Vial, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd, Gujarat, India, NDC 47335-154-40
Reason
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
Identifiers
| code_info | JKM7188A |
|---|
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-1407-2014%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.