Allergan, which made its name with dermatology products like Botox, recalled more than 42,000 tubes of an acne gel that failed to meet specifications during stability testing.
According to the most recent FDA Enforcement Report, Allergan recalled 42,359 tubes of Tazorac in 30-g and 100-g sizes because the gel at the 24-month stability test fell slightly below regulatory specifications for product concentration and content uniformity.
In a letter to retailers, Allergan said the health risk is slight because the product is below specs and that it has not received any reports of adverse events. The voluntary recall actually began in June but was only classified last week by the FDA and posted on its site today..
Allergan last year recalled about 50 lots of some of the eye ointments sold under the brands Refresh, Lacri-Lube and others after receiving a dozen consumer complaints of a small black particle in the product. Allergan determined that the particle was created when unscrewing the cap from the aluminum tube and in some cases getting into the ointment.
Allergan had some other recalls this year, but those were tied to the Actavis generics unit it was recently sold to Teva for $40.5 billion.
- access the recall report here
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