FDA recall D-0807-2023

Product

Guaiatussin AC Sugar-Free, Each teaspoonful (5 mL) contains: Guaifenesin (100 mg), Codeine Phosphate (10 mg), Alcohol (3.5% v/v), a) packaged in a) 118 mL bottles, b) 473 mL bottles and c) 100 unit dose cups, Rx Only, Distributed by: Akorn, Inc., Lake Forest, IL 60045. ALL NDCs

Reason for recall

CGMP Deviations: Firm went out of business and could no longer continue stability studies.

Distribution

Nationwide in the USA and Puerto Rico

Key facts

Status

Ongoing

Initiation date

2023-04-26

Report date

2023-06-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Gurnee, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0807-2023