The Main Pharmaceutical Inspectorate decided to withdraw from the market and use a batch of a medicinal product used, inter alia, in the treatment of gastric and duodenal ulcers. What was the reason for the decision and what drug is it about?
The Main Pharmaceutical Inspectorate withdrew the medicinal product Pantoprazole Reig Jofre, 40 mg, powder for solution for injection, lot number: I118, expiry date: 10.2016, nationwide.
The responsible entity is Laboratorio Reig Jofre, SA, Spain.
The decision was made immediately enforceable.
The reason for the withdrawal from the market was the notification of suspected non-compliance with the quality requirements of the given product series. This suspicion was sent by the Military Pharmaceutical Inspection in Wrocław. The reason for the report was the finding of a foreign body in the product vial.
Intended use:
– Reflux oesophagitis.
– Stomach and duodenal ulcers.
– Zollinger-Ellison syndrome and other conditions related to too much acid production.
Based on: gif.gov.pl
Text: Katarzyna Wróblewska