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
Reported: March 16, 2022 Initiated: February 22, 2022 #D-0652-2022
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
Reason for Recall
Impurity failure at 0-time of the repackaged lot.
Details
- Recalling Firm
- American Health Packaging
- Units Affected
- 89,880 unit-dose cups
- Distribution
- Nationwide in the USA
- Location
- Columbus, OH
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by American Health Packaging. Units affected: 89,880 unit-dose cups.
Why was this product recalled? ▼
Impurity failure at 0-time of the repackaged lot.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 16, 2022. Severity: Moderate. Recall number: D-0652-2022.
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