Hospira Voluntarily Recalls One Lot Each of NaCl and MgSO4 Products

Hospira, Inc. has initiated a voluntary nationwide recall of one lot of 0.9% sodium chloride injection, USP, 250 mL VisIV flex container (NDC 0409-7983-25, Lot 45-110-C6, Expiry March 1, 2016) to the user level due to one confirmed customer report of particulate in a single unit. The foreign particle was confirmed by Hospira as human hair free-floating within the solution. To date, Hospira has not received reports of any adverse events associated with this issue for this lot.

The lot was distributed nationwide from December 2014 through January 2015. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

In the unlikely event that the particulate breaks and pieces are able to pass through the intravenous catheter, injected particulate material may result in localized inflammation, phlebitis, allergic reaction, granuloma formation or microembolic effects (IV only) and/or low-level allergic response. Capillaries which may be as small as the size of a red blood cell, approximately seven microns in diameter, may become occluded. Patients with preexisting condition of trauma or other medical condition that adversely affects the microvascular blood supply are at an increased risk. However, the likelihood of these risks is low as there is no evidence indicating that IV injection of inert particles results in harm to patients when only a small amount over a limited period of time is administered.

Hospira also initiated a voluntary recall of one lot of magnesium sulfate in 5% dextrose, Inj., USP, 10 mg/mL (NDC: 0409-6727-23, Lot 42-120-JT, Expiry December 1, 2015) to the user level due to confirmed customer reports of an incorrect barcode on the primary bag labeling. The barcode on the overwrap is correct; however, there is potential for the primary container barcode to be mislabeled with the barcode for heparin sodium 2000 USP units/1000 mL in 0.9% sodium chloride injection. The product is labeled with the correct printed name on the primary container and overwrap.

Magnesium sulfate in 5% dextrose injection, USP, is a prescription product administered intravenously for the prevention and control of seizures in preeclampsia and eclampsia, respectively. The product is packaged in 50/100 mL container bags and sold 24 bags per carton. The lot was distributed nationwide in the US to wholesalers, distributers, and hospitals from October 2014 to January 2015. Hospira has initiated an investigation to determine the root cause and corrective and preventive actions.

Source: FDA/Hospira (sodium chloride injection) and FDA/Hospira (magnesium sulfate)

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