D-0229-2018 Class II Terminated
FDA drug recall D-0229-2018 was initiated by Sun Pharmaceutical Industries, Inc. on Jan 16, 2018 and is designated Class II. Reason for recall: Lack Of Assurance Of Sterility The recall status is terminated (terminated Sep 14, 2018). Affected quantity: 393 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Jan 31, 2018
- Initiation Date
- Jan 16, 2018
- Termination Date
- Sep 14, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 393 vials
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
Reason for Recall
Lack Of Assurance Of Sterility
Distribution Pattern
Product was distributed nationwide in the USA
Code Information
Lot # JKS0403A Exp 02/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0229-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026