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Akorn, Inc. recalls SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50

Recalled May 20, 2015 · FDA recall D-0997-2015 · Akorn

Hazard
Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole. · FDA Class II
Units
8,400 unit dose cups (20 mL 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 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50383-0824-20), 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

Akorn, Inc. recalls SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE FLAVOR, 20 mL unit dose cup (NDC 50 | RecallWatchUSA