D-0580-2026 Class I Ongoing
FDA drug recall D-0580-2026 was initiated by SUN PHARMACEUTICAL INDUSTRIES INC on May 12, 2026 and is designated Class I. Reason for recall: Presence of Particulate matter: Particulate matter identified as glass. The recall status is ongoing. Affected quantity: 675 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- June 17, 2026
- Initiation Date
- May 12, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 675 vials
Product Description
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.
Reason for Recall
Presence of Particulate matter: Particulate matter identified as glass.
Distribution Pattern
U.S. Nationwide
Code Information
Lot HAG2581B, expires: 05/31/2027