Recalls / Class II
Class IID-0652-2022
Product
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
- Brand name
- Oxycodone Hydrochloride
- Generic name
- Oxycodone Hydrochloride
- Active ingredient
- Oxycodone Hydrochloride
- Route
- Oral
- NDC
- 60687-406
- FDA application
- ANDA204037
- Affected lot / code info
- Lot# 1004276, Exp 11/30/2022
Why it was recalled
Impurity failure at 0-time of the repackaged lot.
Recalling firm
- Firm
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 89,880 unit-dose cups
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2022-02-22
- FDA classified
- 2022-03-11
- Posted by FDA
- 2022-03-16
- Terminated
- 2023-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0652-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.