Gemcitabine For Injection USP — Class II drug recall D-1407-2014
Terminated recall by Caraco Pharmaceutical Laboratories, Ltd., reported 2014-07-02, distributed in OH. Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a l
| Recall number | D-1407-2014 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Caraco Pharmaceutical Laboratories, Ltd., Detroit, MI, United States |
| Recall initiated | 2014-04-09 |
| Classified | 2014-06-20 |
| Reported by FDA | 2014-07-02 |
| Terminated | 2014-09-29 |
| Distributed | OH |
| Quantity | 200 vials |
| Reason classes | sterility |
| NDC | 47335-0154-40 |
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 for recall
Lack of Assurance of Sterility: A particle excursion for a different batch of the same product may lead to a lack of sterility assurance.
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-1407-2014. 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.