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.
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
Lot numbers, UPCs & expiration codes
Lot #: H7044, Exp 05/19
Where it was sold
Distributed nationwide in the USA, Uzbekistan, and Myanmar
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0213-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 9, 2017
- FDA report date
- Jan 17, 2018
- Quantity
- 1,051 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0213-2018, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78842
- Address
- 107 College Rd E
- Code information
- Lot #: H7044, Exp 05/19
- Postal code
- 08540-6623
- Report date
- Jan 17, 2018
- Product type
- Drugs
- Recall number
- D-0213-2018
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 1,051 vials
- Termination date
- Dec 4, 2018
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed nationwide in the USA, Uzbekistan, and Myanmar
- Recall initiation date
- Jan 9, 2017
- Initial firm notification
- Letter
- Center classification date
- Jan 12, 2018