Two years ago, Sun Pharma was before the U.S. Supreme Court defending a label for one of its generic drugs against claims that it didn't adequately warn against risks. Now the labels on some of its drugs are creating another kind of problem, leading to a recall of more than 216,000 bottles of drugs.
According to the most recent FDA Enforcement Report, Mutual Pharmaceutical, a division of Sun Pharmaceutical, is recalling 187,106 bottles of felodipine extended-release blood pressure tablets and 29,660 bottles of the antidepressant imipramine because the varnish is leaching benzophenone.
A Sun Pharma recall notice said that during long-term stability testing, it found trace amounts of benzophenone in the drugs, which it said is unlikely to cause any adverse effects. But out of an abundance of caution, it decided to initiate the recall.
Sun Pharma, which is under careful scrutiny by the FDA right now because of problems at plants in India, has had to deal with a number of recalls lately. Just a couple of weeks ago, the FDA reported that Sun was recalling three lots of bupropion hydrochloride extended-release tablets that were manufactured at its plant in Halol in Gujarat, India, which the FDA has had issues with.
The label problems this time around are a lot less daunting than the case Mutual faced several years ago. The U.S. Supreme Court in 2013 reversed a $21 million state court verdict against Mutual by a woman who said she had gone legally blind after suffering a severe skin reaction three weeks after starting therapy with a generic version of the pain reliever Clinoril that was produced by Mutual. She said the label did not adequately warn against the risk and that the drug was defective.
The court, in a 5-4 decision, found that state-law design-defect claims that are based on the adequacy of a drug's warnings are preempted by federal law. The case was closely watched by the industry, which has argued that if FDA requires that generic drug labels be identical to those accompanying the branded versions, then generic drugmakers shouldn't be held liable for failing to warn patients or doctors about a drug's risks.
- here's is a Sun Pharma recall letter (PDF)