Docetaxel Injection USP — Class II drug recall D-0213-2018
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2018-01-17, distributed nationwide. Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that t
| Recall number | D-0213-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2017-01-09 |
| Classified | 2018-01-12 |
| Reported by FDA | 2018-01-17 |
| Terminated | 2018-12-04 |
| Distributed | Nationwide (US) |
| Quantity | 1,051 vials |
| Reason classes | packaging |
| NDC | 43598-0610, 43598-0610-40, 43598-0611, 43598-0611-11 |
| Lot numbers | 05/19, H7044 |
Product
Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046 INDIA, NDC 43598-611-11
Reason for recall
Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
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-0213-2018. 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.