Hospira has recalled one lot of magnesium sulfate in water for injection following a report of an incorrect barcode on the primary bag labeling, according to the FDA.
The product is typically used for the prevention and control of seizures in pre-eclampsia and eclampsia in pregnant women. Although the barcode on the overwrap of the recalled lot is correct, there is a potential for the primary container barcode to be mislabeled with the barcode for Heparin. The product is labeled with the correct printed name on the primary container and overwrap.
The lot involved was distributed across the U.S. to wholesalers, distributors and hospitals between September and November of last year. The company has begun an investigation into the matter, the agency said.
The voluntary recall is based on the potential for delay in treatment if the product is misused that could cause life-threatening seizures, stroke, cerebral hemorrhage and maternal death, as well as posing a risk of death to the fetus.
"Although serious in nature, the likelihood of this risk to occur is low due to the high detectability of this nonconformance," the warning said.
The sterile injectable specialist, which was bought by Pfizer ($PFE) last year for $15 billion, is not unfamiliar with FDA scrutiny. Last year, the regulatory agency issued a warning to the company in the midst of the Pfizer sale for a plant in Italy. The facility there was cited for not thoroughly investigating 103 customer complaints it received over a two-year period about the discoloration of a product. When it did investigate, the FDA said at the time, it apparently didn't occur to the drugmaker that the problem might have been linked to faulty manufacturing.
- see the FDA posting