Pfizer Recalls More than 582,000 Units of GI Drug


From DCAT Value Chain Insights (VCI)

By Pharma News posted 03-14-2017 12:46

  

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

0 comments
103 views


Thank you for reading DCAT Value Chain Insights (VCI), an information resource from the
Drug, Chemical & Associated Technologies Association (DCAT). 

Learn more and sign up to receive a complimentary subscription 

Permalink

Tag

Comments