Pfizer has issued a voluntary Class III recall for 582,165 vials of the gastrointestinal drug, Protonix (pantoprazole sodium) for injection, equivalent to 40 mg pantoprazole per vial, due to subpotency concerns following out-of-specification results on drug potency at the six-month stability time point. The recall was initiated in November 2016 and noted down by the US Food and Drug Administration on March 10, 2017.
A Class III recall is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
The recall applies to eight lots of product made in France and distributed in Philadelphia by Wyeth Pharmaceuticals, a subsidiary of Pfizer, under a license from Takeda GmbH, based in Konstanz, Germany. The recall includes product bundled in 10-unit cartons of one vial per carton and, separately, 25 x 40 mg vials per carton.
Protonix for injection is a proton pump inhibitor indicated for short-term treatment of gastroesophageal reflux disease and for treating pathological hypersecretion conditions, including Zollinger-Ellison Syndrome.
Source: Food and Drug Administration