DOXOrubicin Hydrochloride Liposome Injection — Class II drug recall D-0229-2018
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2018-01-31, distributed nationwide. Lack Of Assurance Of Sterility
| Recall number | D-0229-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2018-01-16 |
| Classified | 2018-01-19 |
| Reported by FDA | 2018-01-31 |
| Terminated | 2018-09-14 |
| Distributed | Nationwide (US) |
| Quantity | 393 vials |
| Reason classes | sterility |
| NDC | 47335-0049, 47335-0049-40, 47335-0050, 47335-0050-40 |
| Lot numbers | JKS0403A |
| Expiration dates | 2019-02 |
Product
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0229-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.