Why it was recalled
Lack Of Assurance Of Sterility
Product description
DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40
Lot numbers, UPCs & expiration codes
Lot # JKS0403A Exp 02/2019
Where it was sold
Product was distributed 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-0229-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 16, 2018
- FDA report date
- Jan 31, 2018
- Quantity
- 393 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
Original FDA data
Every field from FDA enforcement report D-0229-2018, exactly as published.
Show all FDA fields
- City
- Cranbury
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78947
- Address
- 270 Prospect Plains Rd
- Code information
- Lot # JKS0403A Exp 02/2019
- Postal code
- 08512-3605
- Report date
- Jan 31, 2018
- Product type
- Drugs
- Recall number
- D-0229-2018
- Classification
- Class II
- Recalling firm
- Sun Pharmaceutical Industries, Inc.
- Product quantity
- 393 vials
- Termination date
- Sep 14, 2018
- Reason for recall
- Lack Of Assurance Of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40
- Distribution pattern
- Product was distributed nationwide in the USA
- Recall initiation date
- Jan 16, 2018
- Initial firm notification
- Letter
- Center classification date
- Jan 19, 2018