Sagent Pharmaceuticals has initiated a recall of two lots of its chemotherapy drug, Docetaxel Injection, USP, due to possible contamination stemming from particulate matter from the stopper, as reported by the U.S. Food and Drug Administration (FDA).
The affected batches are as follows:
- The 160 mg/16 mL Docetaxel Injection comes with lot number F1030001, NDC 25021-254-16, and an expiration date of December 2024.
- The 80 mg/8 mL product carries lot number F1040001, NDC 25021-254-08, and also an expiration date of December 2024.
These products were distributed nationwide by Sagent from October 11, 2023, to April 11, 2024.
The FDA has warned that intravenous administration of an injectable drug containing particulate matter could lead to severe adverse effects such as vein inflammation, granuloma, and blockage of blood vessels in critical organs like the heart, lungs, or brain, potentially resulting in stroke or other life-threatening conditions.
The recall stems from a customer complaint, although Sagent has not yet received any reports of adverse events associated with the recalled batches.
Customers are advised to quarantine and cease the distribution of the affected lots, and to return the products as instructed. Notifications are being sent via FedEx, encompassing return arrangements for the recalled items.
In a related recall, Hospira, Inc., a subsidiary of Pfizer Inc., announced last week the recall of select lots of Buprenorphine Hydrochloride Injection Carpuject Units and Labetalol Hydrochloride Injection Carpuject Units due to issues with incomplete crimp seals.
For additional health-related news, please visit [RTT News](https://www.rttnews.com/content/health.aspx).
