3 pharma companies recall generic prescription drugs over questionable test data

Health Canada says three pharmaceutical companies are recalling all lots of their prescription generic medication over concerns about the integrity of tests used to show their products work the same as the brand-name versions of the drugs.

Accel Pharma Inc., Mint Pharmaceuticals Inc., and Pharmascience Inc. have recalled the following products:

Accel-Ondansetron ODT is used to prevent nausea and vomiting related to chemotherapy, Mint-Betahistine is used for reducing the episodes of recurrent vertigo associated with Ménière’s disease, and PMS-Pirfenidone is used to treat a serious, long-term lung disease known as idiopathic pulmonary fibrosis (IPF).

Health Canada says the affected products relied on the bioequivalence test data conducted by India-based Synapse Labs Pvt. Ltd., which the European Medicines Agency noted inspections last December found “irregularities” and “inadequacies” in documentation and procedures used by the lab raised “serious concerns about the validity and reliability of data.”

“As a result, the affected products can no longer be considered safe and effective,” the federal agency said in its recall notice.

Health Canada says the companies have stopped the sale and have recalled all lots of the affected products until they can provide additional information to demonstrate that they are safe and effective.

Consumers are asked to return the affected products to their local pharmacy for replacement and proper disposal. Anyone unsure whether the product they are using is affected is asked to check with their pharmacy.