Orifarm starts Cialis recall on counterfeit concerns

Danish parallel importer Orifarm has recalled batches of erectile dysfunction product Cialis after the Greek authorities raised concerns about possible counterfeits.

The recall was announced by Orifarm's subsidiary in Leverkusen, Germany, and involves blisters of the drug with batch numbers that do not match those printed on the outer packaging, according to a report in the European Compliance Academy's GMP newsletter.

Citing pharmacy group Arzneimittelkommission der Deutschen Apotheker (AMK), the report recommends that pharmacists check packs of 20mg Cialis (tadalafil) tablets with the batch numbers A05673 and A05668 to see whether the blisters have been falsified.

Orifarm is the largest pharma supplier in Denmark with a turnover of €759m ($856m) last year from parallel import and supply operations in Scandinavia, Germany, Holland, Czech Republic and the UK.

This is not the first time that Orifarm has been forced to order a recall of medicines because of suspected falsification.

In 2011 the company withdrew stocks of Gilead Sciences' HIV treatment Truvada (emtricitabine and tenofovir disoproxil fumarate), while in 2014 it recalled batches of Pfizer's kidney and pancreatic cancer drug Sutent (sunitinib) and last year did likewise with a batch of Sanofi's anti-platelet drug Clexane (enoxaparin).

It has been suggested in the past that parallel imports can be a weak link in the supply chain for pharmaceuticals and could allow counterfeits to enter legitimate distribution channels. However, the European Association of Euro-Pharmaceutical Companies (EAEPC) - which represents parallel traders - points to several cases in which its members have identified counterfeits and acted to prevent further dissemination.

The EAPEC is one of the partners in the European Stakeholder Model (ESM) for pharmaceutical product serialization, which is designed to meet the safety features requirements of the Falsified Medicines Directive (FMD).

Earlier this year, Orifarm was involved in a legal dispute in Germany involving a request to sell medicinal products sourced from Romania that had temporarily left the legal supply chain. The court rule that to do so was contrary to the requirements of the EU's Good Distribution Practice (GDP) Directive and could allow counterfeit or substandard medicines onto the market.