Akorn Voluntarily Recalls Antibacterial Due to Dissolution Issues
Akorn Pharmaceuticals is voluntarily recalling more than 362,000 units of sulfamethoxazole/trimethoprim oral suspension because the sulfamethoxazole portion doesn’t dissolve in liquid.
The company’s grape-flavored formulation, 200 mg/40 mg per 5 ml in 16-ounce bottles, accounts for the bulk of products with 326,666 units being recalled, followed by 27,648 bottles of a cherry-flavored version. The recall also includes 8,400 units of cherry-flavored sulfamethoxazole/trimethoprim oral suspension in 20 ml dose cups.
In all, 50 lots are affected, FDA enforcement reports show.
The Lake Forest, Ill., drugmaker initiated the Class II recall of the combination antibacterial on March 17.
Akorn spokesman Dewey Steadman saysthe recalled products were manufactured by Hi-Tech Pharmacal prior to its purchase by Akorn in April 2014. While the company believes little of the affected product remains on the market, Akorn initiated the recall following customer reports about ineffective units.
Sulfamethoxazole products recently manufactured by Akorn in the former Hi-Tech facility are not involved in this recall, Steadman notes.
The enforcement reports for the grape liquid, cherry liquid and dose cups are available at www.fdanews.com/05-22-15-Grape.pdf, www.fdanews.com/05-22-15-Cherry.pdf and www.fdanews.com/05-22-15-DoseCups.pdf, respectively. — Kellen Owings