Drug Safety Alerts

Dextrose 25% pre-filled 10 mL syringes Class I Recall

5/31/2017

On May 31, 2017, the United States Food and Drug Administration (FDA) issued notice regarding a Class I recall of dextrose 25% pre-filled 10 mL syringes NDC # 00409-1775-10 manufactured by Hospira. This recall was issued due to the presence of particulate matter, identified as a human hair, found within an internal sample syringe. In the event that the particulate is administered to a patient, it could result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or systemic allergic response to the particulate. Administration of the particulate could also result in localized phlebitis, pulmonary emboli, pulmonary granulomas, immune system dysfunction, pulmonary dysfunction, and pulmonary infarction. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

This recall affects lot # 58382EV exp. 10/01/17. The lot may be followed by 01 or 02. The affected lot went into distribution February 2016. No other lots are affected by this recall.

Please note: This recall was originally issued on April 24, 2017. The FDA classified this as a Class I recall on May 31, 2017.

CVS Caremark Response:

Please note: This product is not carried by the CVS Caremark Mail Service Pharmacies.

For more information regarding this recall, healthcare providers may contact Pfizer Medical Information at 1-800-615-0187, Monday through Friday, 8:00 AM to 7:00 PM (ET) or visit www.hospira.com. You may also contact the FDA consumer inquiry line at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.accessdata.fda.gov.