US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 17, 2015 (11 years ago)

SULFAMETHOXAZOLE AND TRIMETHOPRIM ORAL SUSPENSION, USP 800 mg/ 160 mg per 5mL, GRAPE…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

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

Recalling firm
Akorn, Inc.
NDC code
50383-0824-20
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0997-2015

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Sulfamethoxazole recalls

See all