Why it was recalled
Impurity failure at 0-time of the repackaged lot.
Product description
Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40
Lot numbers, UPCs & expiration codes
Lot# 1004276, Exp 11/30/2022
Where it was sold
Nationwide in the USA
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-0652-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 22, 2022
- FDA report date
- Mar 16, 2022
- Quantity
- 89,880 unit-dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- American Health Packaging
Original FDA data
Every field from FDA enforcement report D-0652-2022, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 89670
- Address
- 2550 John Glenn Ave Ste A
- Code information
- Lot# 1004276, Exp 11/30/2022
- Postal code
- 43217-1188
- Report date
- Mar 16, 2022
- Product type
- Drugs
- Recall number
- D-0652-2022
- Classification
- Class II
- Recalling firm
- American Health Packaging
- Product quantity
- 89,880 unit-dose cups
- Termination date
- Jul 16, 2023
- Reason for recall
- Impurity failure at 0-time of the repackaged lot.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL per Cup, 1 Tray of 10 Cups, Rx Only, For Institutional Use Only, American Health Packaging, Columbus, OH 43217. UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77, Unit Dose NDC#: 60687-406-40
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Feb 22, 2022
- Initial firm notification
- Letter
- Center classification date
- Mar 11, 2022