Oxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
American Health Packaging is recalling one lot of Oxycodone Hydrochloride Oral Solution due to impurity failure detected at initial testing of the repackaged product.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this as a Class II recall. An impurity failure in a controlled opioid medication represents a significant quality-control defect that could result in dosing or safety issues. Although no specific illnesses or injuries are reported in the source text, the hazard involves a quality-control failure in a prescription opioid affecting a substantial quantity of units, which justifies a Severe classification per the rubric for FDA Class II recalls.
Plain-English summary
American Health Packaging is recalling Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, distributed nationwide in the USA. The recall affects 89,880 unit-dose cups from Lot #1004276 with an expiration date of 11/30/2022. The product is intended for institutional use only and is supplied in trays of 10 cups per unit dose.
The recall was initiated due to impurity failure detected at the time of repackaging. The affected lot's packaging includes the following identifiers: UPC (01) 003 60687 406 40 4; Case NDC#: 60687-406-77; Unit Dose NDC#: 60687-406-40.
Healthcare facilities and institutions that received this product should quarantine and return it to American Health Packaging. Patients should not discontinue oxycodone therapy without consulting their healthcare provider. Healthcare providers should contact American Health Packaging to arrange return or replacement of affected units.
The recalled product
- Product
- OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
- Brand
- OXYCODONE HYDROCHLORIDE
- Manufacturer
- American Health Packaging
- Hazard
- impurity-failure
- quality-control-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot# 1004276
- Exp 11/30/2022
Distribution
Distributed nationwide across the United States.
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