Why it was recalled
CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Product description
Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. 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-0815-2023
- 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-0815-2023, 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-0815-2023
- 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
- Lactulose Solution, USP (For oral or rectal administration), 30 mL Unit Dose Cups, Rx Only, Distributed by: Akorn, Inc., Gurnee, IL 60031. 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