Valeant labeling snafu affects Sanofi's Aplenzin, as well as Valeant's vaseretic

The 206,000 bottles of blood pressure medication vaseretic that Valeant ($VRX) has been recalling is not the only product affected by a packaging snafu that resulted in outdated package inserts. The drugmaker has also been retrieving 19 lots of the antidepressant Aplenzin that it makes for Sanofi ($SNY).

According to an FDA Enforcement Report posted today, Valeant started recalling more than 100,000 bottles of the drug in June because some of the lots had gotten inserts that were made irrelevant in August 2012 when the FDA approved an updated version. According to a letter from Valeant and posted by distributor Smith Drug, no adverse events have been reported as a result of the problem.

Two weeks ago, the FDA Enforcement Report indicated that the Canadian drugmaker was recalling 206,000 bottles of blood pressure medicine vaseretic because of labeling issues. It is also recalling more than 35,000 tubes of hydrocortisone butyrate cream for not meeting potency standards at the 18-month mark.

Valeant has had a number of manufacturing issues this year, including a warning letter for the manufacturing of Sculptra Aesthetic, an antiaging injection that was handled by a contractor. Valeant sold off that product in July. Earlier this year, Valeant's Bausch + Lomb unit recalled 850,000 lots of Muro 128 ointment, as well as 35,000 tubes of an unbranded sodium chloride product sold by Major Pharmaceuticals, after consumer complaints. It determined there was nothing wrong with its manufacturing but that the products had probably frozen during shipping.

None of these stumbles have meant much to its bottom line. Last month, the drugmaker reported $275.4 million in quarterly profit, amounting to 81 cents per share on revenues of $2.06 billion. The company also raised its guidance for Q4 and 2014 and said it expected its earnings next year to be 10% better than earlier projected, hitting $10 per share.

- here's the FDA notice
- and here
- and here
- read Sanofi's and Valeant's recall letters (PDF)