Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.
Reported: March 20, 2019 Initiated: March 6, 2019 #D-1001-2019
Product Description
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.
Reason for Recall
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Details
- Recalling Firm
- Dr. Reddy's Laboratories, Inc.
- Units Affected
- 5,755 vials
- Distribution
- Nationwide in the USA
- Location
- Princeton, NJ
Frequently Asked Questions
What product was recalled? ▼
Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.. Recalled by Dr. Reddy's Laboratories, Inc.. Units affected: 5,755 vials.
Why was this product recalled? ▼
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 20, 2019. Severity: Moderate. Recall number: D-1001-2019.
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