FDA-Drug2026-06-17Class IPACKAGING DEFECT
Sun Pharmaceutical doxorubicin injection recalled for glass particles
What this means
Sun Pharmaceutical's doxorubicin hydrochloride liposome injection vials were found to contain glass particles. The affected vials are lot HAG2581B, which expire in May 2027. About 675 vials were distributed nationwide.
- If you have vials from lot HAG2581B, do not use them.
- Contact your pharmacy or healthcare provider immediately.
- Return unused vials to your pharmacy or healthcare facility.
The agency's original wording
Hazard
Presence of Particulate matter: Particulate matter identified as glass.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide
Affected count
675 vials
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0580-2026More Sun Pharmaceutical recalls
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