Indian pharmaceutical giant Sun Pharma has initiated a voluntary recall of a single lot of Doxorubicin hydrochloride liposome injection in the United States. The recall was triggered following the discovery of glass particles in several vials during the production phase.
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Product: Doxorubicin hydrochloride liposome injection.
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Scope: One batch containing 675 vials.
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Indications: Treatment for ovarian cancer, multiple myeloma, and Kaposi sarcoma.
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Expiry Date: The affected vials were scheduled to expire at the end of next May.
Health Risks and Safety Administering intravenous medications contaminated with foreign glass particulates poses significant health risks:
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Local Reactions: Potential for irritation and swelling at the injection site.
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Severe Complications: Glass fragments may block blood vessels, potentially leading to life-threatening embolic events or clotting.
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Current Status: As of the May 13 notice, Sun Pharma reported no adverse events linked to the suspect batch.
Industry Context Glass particulate contamination remains a recurring issue in the pharmaceutical sector, prompting multiple regulatory actions recently:
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Pfizer (Oct 2023): Recalled sodium bicarbonate and lidocaine injectables for similar concerns.
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GSK (2023): Pulled asthma medication Nucala in Taiwan after glass particles were found in a reconstituted vial.
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Zydus (2024): Issued an FDA warning letter partly for failing to root out sources of cross-contamination, including glass.
Sun Pharma emphasized that it has investigated the source of the issue and implemented corrective and preventative actions.