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Serious riskFDA DrugClass I

Sun Pharmaceutical doxorubicin injection recalled for glass particles

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.

From the FDA notice · Read the official notice ↗ · All Sun Pharmaceutical recalls

What to do

  1. If you have vials from lot HAG2581B, do not use them.
  2. Contact your pharmacy or healthcare provider immediately.
  3. Return unused vials to your pharmacy or healthcare facility.
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

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.
Sold in
Nationwide
Made for
Adults (0 months and older)

Details

Units affected
675 vials
Illnesses reported
None reported
Manufactured in
2 Independence Way, N/A, Princeton, NJ, United States
Classification
Class I
Recall number
D-0580-2026

In the FDA's words

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. Presence of Particulate matter: Particulate matter identified as glass. Lot HAG2581B, expires: 05/31/2027 Distribution: U.S. Nationwide Affected quantity: 675 vials
Hazard
Presence of Particulate matter: Particulate matter identified as glass.

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