Doxorubicin liposome injection vials contain glass particulate matter
Doxorubicin Hydrochloride Liposome Injection, 50 mg/25 mL single-dose vials, is being recalled because of particulate matter identified as glass. 675 vials are affected.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I recall, which the rubric floors at Severe; no injury is reported in the source, so it does not escalate to Critical.
Plain-English summary
Doxorubicin Hydrochloride Liposome Injection, 50 mg/25 mL (2 mg/mL), 25 mL sterile single-dose vials, prescription only, manufactured for Northstar Rx LLC of Memphis, Tennessee by Sun Pharmaceutical Industries, is being recalled. The action covers 675 vials.
The stated reason is the presence of particulate matter identified as glass. The FDA classified the action as Class I, its most serious classification.
The affected lot is HAG2581B, expiring 05/31/2027. Distribution was USA nationwide. The vials are supplied to healthcare providers rather than sold directly to consumers.
Facilities should identify affected stock using the lot number above, quarantine it, and follow the instructions issued by the manufacturer.
The recalled product
- Product
- DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE)
- Brand
- DOXORUBICIN HYDROCHLORIDE
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Injectable oncology drug
- Affected units
- 675
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot HAG2581B
- expires: 05/31/2027
UPCs (1)
- 0372603200010
Distribution
Distributed nationwide across the United States.
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