Drug product
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.
D-0580-2026
Product summary
- Event
- Event 98921
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 675 vials
- Official record key
drug-enforcement:D-0580-2026
Official wording
Reason: Presence of Particulate matter: Particulate matter identified as glass.
Code information: Lot HAG2581B, expires: 05/31/2027
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Particulate matter