For the second time in recent months, Pfizer ($PFE) is having to recall hundreds of thousands of bottles of a drug when one was found to contain the wrong tablet. Pfizer says a single 100 mg tablet of Pristiq Extended Release was found in a 50 mg bottle but the drugmaker is taking no chances and is recalling four lots of the the antidepressant drug.
The four lots of the 50 mg Pristiq amount to 220,761 bottles, according to the FDA Enforcement Report. Pfizer started the recall in mid April. Pfizer picked up Pristiq in its $68 billion buyout 5 years ago. While not a blockbuster, Pristiq has performed well for Pfizer, bringing in $698 million in revenue last year, up 11%.
In March, Pfizer announced it was recalling two lots of different doses of Effexor XR and one lot of its Greenstone-branded Venlafaxine, its branded generic version. The recalls added up to 104,450 bottles. The heart drug found in an Effexor XR bottle was Tikosyn, a med used to treat irregular heartbeats. The drugmaker said the risk that any other bottles might be affected was slim, but it decided to recall the three lots of Effexor XR as a precaution since all three were run on the same packaging line.
This kind of packaging line issue does happen. Last year, AbbVie ($ABBV) recalled one lot, 28,500 bottles, of 150 mcg tablets of the thyroid drug Synthroid after tablets of the lower 75 mcg dosage were found in one bottle in that lot. Novartis ($NVS) started its own recall in April of one lot of attention deficit hyperactivity disorder (ADHD) drug Ritalin 10 mg tablets and one lot of 20 mg tablets, nearly 22,000 bottles, because medication guides attached to the package inserts were printed with information related to its sustained-release product instead.
- here's the FDA notice