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
Reported: January 17, 2018 Initiated: January 9, 2017 #D-0213-2018
Product Description
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.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 1,051 vials
- Distribution
- Distributed nationwide in the USA, Uzbekistan, and Myanmar
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 1,051 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on January 17, 2018. Severity: Moderate. Recall number: D-0213-2018.
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