FDA recall D-0916-2018

Product

Acetylcysteine for Injection 6 g/30 mL (200 mg/mL). Rx Only. Manufactured by Akron Inc., Lake Forest, IL 60045. NDC 17478-660-30.

Reason for recall

CGMP Deviations

Distribution

U.S. Nationwide

Key facts

Status

Terminated

Initiation date

2018-06-22

Report date

2018-07-18

Termination date

2020-11-06

Voluntary/Mandated

—

Location

Decatur, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0916-2018