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

Recall date

March 17, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0997-2015

FDA classification

Class II

Brand / firm

Akorn, Inc.

Sold / distributed

Nationwide and Puerto Rico

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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