FDA Drug recall D-0213-2018
Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd
- FDA Drug
- Class II
- terminated
- Published 2018-01-17
On 2018-01-17 the FDA classified a Class II recall of Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd by Dr Reddy S Laboratories, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0213-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-09 |
| Published | 2018-01-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
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
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.
Identifiers
| ndc | 43598-611-11 |
|---|---|
| ndc | 43598-610-40 |
| code_info | Lot #: H7044, Exp 05/19 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0213-2018%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.