Akorn, Inc. recalls SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (N
Recalled May 20, 2015 · FDA recall D-0996-2015 · Akorn
Hazard
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. · FDA Class II
Units
326,666 bottles (16 fl. oz. each)
Sold at
Nationwide and Puerto Rico
Description
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.
Product
SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP,200 mg/ 40 mg per 5mL, GRAPE FLAVOR, 16 fl oz (473 mL) bottles (NDC 50383-0824-16), Rx only, HI-TECH PHARMACAL CO. INC, Amityville, NY 11701
Manufacturer(s)
Akorn, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →