FDA recall D-0696-2017

Akorn Inc · Class II · drug

Product

Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 mL , Grape Flavor, Rx Only, 16 fl oz. (473 mL), HI-TECH PHARMACAL CO., INIC, Amityville, NY 11701, NDC 50383-824-16

Reason for recall

Failed Dissolution Specifications

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2017-03-13
Report date: 2017-05-10
Termination date: 2019-07-09
Voluntary/Mandated: Voluntary: Firm initiated
Location: Lake Forest, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0696-2017