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

Recall Number: D-0997-2015

Firm: Akorn, Inc.

Classification: Class II

Status: Terminated

Report Date: 20150520

Initiation Date: 20150317

Termination Date: 20171227

Failed Dissolution Specifications: Out of specification for dissolution of sulfamethoxazole.

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