U.S. OTC and generics maker Akorn ($AKRX) and its Hi-Tech Pharmacal unit have had a number of recalls lately involving its liquid products, including more than 7,200 bottles of dental mouth rinse which the FDA says failed impurities testing.
According to the FDA Enforcement Report, Akorn has three separate recalls of chlorhexidine gluconate oral rinse, amounting to 128 lots, that the agency said was out of specification for an unknown impurity. That amounts to about 909 gallons of the rinse. The company, which has headquarters in both the U.S. and India, began the voluntary recall of the products in late March, but the FDA just this week classified them as class II.
On top of that, the drugmaker is voluntarily recalling 57,920 bottles of sulfacetamide sodium ophthalmic solution that failed antimicrobial effectiveness testing.
Lake Forest, IL-based Akorn bought Hi-Tech in 2013 for $640 million and then grabbed VersaPharm the next year for $440 million in what CEO Raj Rai said was an effort to double its revenues. He has accomplished that and more, tripling revenues to $985 million last year from $317.7 million in 2013, after having to restate some financials tied to the two acquired companies.
Along the way, Akorn has had some significant recalls when measured in quantities. Last year it recalled more than 355,000 bottles of its generic of Bactrim made for children after it was found to be out of specification for the dissolution of sulfamethoxazole, one of two active ingredients in the product. A couple of months later, it recalled hundreds of thousands of bottles of the generic anxiety drug hydroxyzine hydrochloride because it failed impurities specifications.
- find the recalls here