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Dextrose Injection for Infants Recalled Due to Particulate Matter


On April 24, 2017, Hospira, Inc., a Pfizer company, recalled one lot of 25% Dextrose Injection, USP, (Infant) pre-filled syringe to the hospital/user level due to the presence of particulate matter, identified as 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.

 

25% Dextrose Injection, USP, (Infant) is indicated for use via slow IV injection to treat symptomatic episodes of hypoglycemia (fasting blood glucose < 40 mg/100 ml) in neonates or in older infants to restore depressed blood glucose values and control symptoms.

 

25% Dextrose Injection, USP, (Infant) 2.5 grams (250 mg/mL), 10 mL Single-dose prefilled syringe, NDC:0409-1775-10, Lot 58382EV, Expiry Date 1OCT 2017 is packaged in a carton containing 1 pre-filled syringe per carton, 5 x 10 syringes per case. The lot was distributed between February 2016 and October 2016 nationwide in the United States and Puerto Rico.

 

See the FDA Safety Alert

 

See the Recall

 

See also Medical Law Perspectives, April 2017 Report: Gestational Diabetes: The Effects on Mothers, Babies, and Providers May Not Be Sweet

 

See also Medical Law Perspectives, August 2015 Report: Pediatrician Liability for Childhood Disease Complications

 

See also Medical Law Perspectives, January 2015 Report: Mothers, Infants, and Obstetrical Injuries: Labor and Delivery Liability

 

See also Medical Law Perspectives, May 2013 Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication

 

See the Medical Law Perspectives March 5, 2015, Blog: Patients Injected with Unsterile Training IV Solution Injured

 

 

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