Recalls / Class II
Class IID-1001-2019
Product
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.
- Brand name
- Docetaxel
- Generic name
- Docetaxel
- Active ingredient
- Docetaxel
- Route
- Intravenous
- NDCs
- 43598-258, 43598-259, 43598-389
- FDA application
- ANDA204193
- Affected lot / code info
- Lot#: H7081, Exp 07/2019
Why it was recalled
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
Recalling firm
- Firm
- Dr. Reddy's Laboratories, Inc.
- Manufacturer
- Dr. Reddy's Laboratories Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 107 College Rd E, N/A, Princeton, New Jersey 08540-6623
Distribution
- Quantity
- 5,755 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-03-06
- FDA classified
- 2019-03-12
- Posted by FDA
- 2019-03-20
- Terminated
- 2022-05-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1001-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.