Food, drugs, devices › Sun Pharmaceutical Industries, Inc.
Drug recall: DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmace
Sun Pharmaceutical Industries, Inc. (Cranbury, NJ) initiated this drug recall on 16 Jan 2018; FDA lists 1 product record under event 78947, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.
Status: Terminated, terminated 14 Sep 2018. Initiation: voluntary: firm initiated. Sun Pharmaceutical Industries, Inc. has 94 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Sun Pharmaceutical Industries, Inc., Cranbury, NJ.
Reason for recall
"Lack Of Assurance Of Sterility"
Distribution
"Product was distributed nationwide in the USA"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| D-0229-2018 | 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 | 393 vials | Class II | Terminated | 31 Jan 2018 |
Context
Other enforcement events for Sun Pharmaceutical Industries, Inc.
All 94 events for Sun Pharmaceutical Industries, Inc.
Questions and answers
Why was this drug recalled?
FDA's record gives the reason for recall as: "Lack Of Assurance Of Sterility"
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "Product was distributed nationwide in the USA"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Sep 2018. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.