FDARecalled Jun 7, 2023 · #D-0807-2023
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...
Hazard
Class II — temporary health risk
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CGMP Deviations: Firm went out of business and could no longer continue stability studies. Classification: Class II Distribution: Nationwide in the USA and Puerto Rico
Product details
- 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
- Type
- Drugs
- Manufacturer
- Akorn, Inc.
- Model numbers
- —
- UPCs
- —