FDA Recall Ongoing Historical recordClass II
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
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Published
- June 7, 2023
- Distribution
- Nationwide
