Why it was recalled
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product description
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
Lot numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide in the USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0807-2023
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 26, 2023
- FDA report date
- Jun 7, 2023
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Akorn, Inc.
Original FDA data
Every field from FDA enforcement report D-0807-2023, exactly as published.
Show all FDA fields
- City
- Gurnee
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 91788
- Address
- 5605 Centerpoint Ct Ste A
- Code information
- All Lots
- Postal code
- 60031-5278
- Report date
- Jun 7, 2023
- Product type
- Drugs
- Recall number
- D-0807-2023
- Classification
- Class II
- Recalling firm
- Akorn, Inc.
- Reason for recall
- CGMP Deviations: Firm went out of business and could no longer continue stability studies.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA and Puerto Rico
- Recall initiation date
- Apr 26, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 1, 2023