Why it was recalled
Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
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.
Lot numbers, UPCs & expiration codes
Lot#: H7081, Exp 07/2019
Where it was sold
Nationwide in the USA
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-1001-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 6, 2019
- FDA report date
- Mar 20, 2019
- Quantity
- 5,755 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-1001-2019, exactly as published.
Show all FDA fields
- City
- Princeton
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 82323
- Address
- 107 College Rd E
- Code information
- Lot#: H7081, Exp 07/2019
- Postal code
- 08540-6623
- Report date
- Mar 20, 2019
- Product type
- Drugs
- Recall number
- D-1001-2019
- Classification
- Class II
- Recalling firm
- Dr. Reddy's Laboratories, Inc.
- Product quantity
- 5,755 vials
- Termination date
- May 16, 2022
- Reason for recall
- Defective Container: complaint for seal and cap vial issues that could lead to a lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Mar 6, 2019
- Initial firm notification
- Letter
- Center classification date
- Mar 12, 2019