Guaiatussin AC Sugar-Free recall: CGMP Deviations
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
Why was Guaiatussin AC Sugar-Free recalled?
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots
- 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
- Recalling firm
- Akorn, Inc.
- Quantity
- N/A
- Distribution
- Nationwide in the USA and Puerto Rico
- Recall date
- June 7, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)