Recalls / Class II
Class IID-0213-2018
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
- Brand name
- Docetaxel
- Generic name
- Docetaxel
- Active ingredient
- Docetaxel
- Route
- Intravenous
- NDCs
- 43598-610, 43598-611
- FDA application
- ANDA204193
- Affected lot / code info
- Lot #: H7044, Exp 05/19
Why it was 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.
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
- 1,051 vials
- Distribution pattern
- Distributed nationwide in the USA, Uzbekistan, and Myanmar
Timeline
- Recall initiated
- 2017-01-09
- FDA classified
- 2018-01-12
- Posted by FDA
- 2018-01-17
- Terminated
- 2018-12-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0213-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.