FDA recall D-0997-2015

Akorn, Inc. · Class II · drug

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

Reason for recall

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

Distribution

Nationwide and Puerto Rico

Key facts

Status: Terminated
Initiation date: 2015-03-17
Report date: 2015-05-20
Termination date: 2017-12-27
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0997-2015