Akorn Guaiatussin AC Sugar-Free Cough Suppressant Recalled Due to Manufacturing Deviations
Akorn, Inc. is recalling all lots of Guaiatussin AC Sugar-Free nationwide due to manufacturing deviations. The firm went out of business and could not continue stability studies.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall involving CGMP deviations and incomplete stability studies. No illnesses or injuries have been reported, and the hazard remains theoretical.
Plain-English summary
Akorn, Inc. is recalling all lots of Guaiatussin AC Sugar-Free, a cough suppressant containing guaifenesin (100 mg) and codeine phosphate (10 mg) per 5 mL dose. The product was distributed nationwide in the United States and Puerto Rico in 118 mL bottles, 473 mL bottles, and 100-unit dose cups.
The recall was initiated because Akorn, Inc. went out of business and could no longer continue stability studies. This represents a current good manufacturing practice (CGMP) deviation.
Patients currently using this product should consult their healthcare provider about alternatives. Any remaining product should be disposed of or returned to a pharmacy.
The recalled product
- 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
- Manufacturer
- Akorn, Inc.
- Category
- Drug — Cough Suppressant
- Hazard
- cgmp-deviation
- incomplete-stability-testing
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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