Aurobindo Pharma Limited issued a recall for a generic version of the injectable heartburn treatment Protonix because some vials appeared to be discolored with a possible contaminant.
Pantoprazole sodium is the active ingredient in Protonix. It is a class of acid-reducing drugs called proton pump inhibitors, or PPIs, which work by blocking the production of acid in the stomach. The medication is intended to be used short-term (7 to 10 days) in adult patients to treat esophageal reflux disease (GERD) and a history of erosive esophagitis.
The recall affects 29,800 vials of pantoprazole sodium for injection, 40mg per vial, single dose. It is classified as a Class III recall, which is a less serious type of recall reserved for products that are not likely to cause adverse health consequences to patients. The stated reason or the recall was “discoloration: some vials were found to contain powder with a yellowish-brownish appearance.”
Any side effects associated with use of affected Aurobindo Pharma Limited generic Protonix for injection should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.
Source: Economic Times