FDA DrugsClass I
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-d...
Published: June 17, 2026Recall ID: D-0580-2026Category: drugsCountry: US
Reason for Recall / Hazard
Presence of Particulate matter: Particulate matter identified as glass.
Product Description & Identification
DOXOrubin Hydrochloride Liposome injection, 50 mg/25 mL (2mg/mL), 25 mL single-dose vials, Sterile, Rx only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol, Gujarat, India, NDC 72603-200-01.
Additional Source Details
| Field | Value |
|---|---|
| City | Princeton |
| State | NJ |
| Openfda › Upc | 0372603200010 |
| Openfda › Unii | 82F2G7BL4E |
| Openfda › Route | INTRAVENOUS |
| Openfda › Rxcui › 1 | 1790115 |
| Openfda › Rxcui › 2 | 1790127 |
| Openfda › Spl id | 010a4e76-dedf-4f7b-b4de-1d78f91c2095 |
| Openfda › Brand name | DOXORUBICIN HYDROCHLORIDE |
| Openfda › Spl set id | ddf55319-bf62-4ec7-8be2-ef97188837c4 |
| Openfda › Package ndc › 1 | 72603-103-01 |
| Openfda › Package ndc › 2 | 72603-200-01 |
| Openfda › Product ndc › 1 | 72603-103 |
| Openfda › Product ndc › 2 | 72603-200 |
| Openfda › Generic name | DOXORUBICIN HYDROCHLORIDE |
| Openfda › Product type | HUMAN PRESCRIPTION DRUG |
| Openfda › Substance name | DOXORUBICIN HYDROCHLORIDE |
| Openfda › Manufacturer name | NorthStar RxLLC |
| Openfda › Application number | ANDA203263 |
| Openfda › Is original packager | true |
| Event id | 98921 |
| Address 1 | 2 Independence Way |
| Address 2 | N/A |
| Code info | Lot HAG2581B, expires: 05/31/2027 |
| Postal code | 08540-6620 |
| Report date | 20260617 |
| Product type | Drugs |
| Product quantity | 675 vials |
| Reason for recall | Presence of Particulate matter: Particulate matter identified as glass. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260512 |
| Initial firm notification | |
| Center classification date | 20260605 |
Overview
- Recalling FirmSUN PHARMACEUTICAL INDUSTRIES INC
- StatusOngoing
- Risk LevelClass I
- DistributionU.S. Nationwide