American Health Packaging recalls 5mg/5mL oxycodone oral solution due to impurity failure in repackaged lots. This controlled substance is for institutional use only.
Impurity failure at 0-time of the repackaged lot.
American Health Packaging is recalling a specific oxycodone oral solution product due to impurity issues in repackaged lots. This controlled substance is intended for institutional use only and requires immediate attention due to potential safety risks.
The recall states there was an impurity failure at the time of repackaging the lot. This could mean the product contains harmful substances that might cause adverse effects when used as intended. However, the specific nature of the impurity and its potential impact are not clearly described in the recall notice.
Institutional users of this prescription opioid solution are most at risk. The product is only available through prescription and for institutional use, so affected individuals would be healthcare facilities or pharmacies.
Check for the product name 'Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL' with the lot number 1004276. This product was sold with a specific UPC code (01 003 60687 406 40 4) and NDC numbers.
Verify the lot number 1004276 and NDC numbers 60687-406-77 (case) and 60687-406-40 (unit dose) on the product label.
The recall states there was an impurity failure at the time of repackaging, but the specific risks are not clearly described. The product is not safe to use without further verification.
The recall does not specify a remedy, so there is no action required beyond checking the product details for the lot number and NDC numbers.
No, this product is prescription-only and for institutional use only.
We’ve drafted a message you can send American Health Packaging to request your refund or repair — edit it as you like.
Subject: Recall D-0652-2022 — American Health Packaging American Health Packaging Hello, I own a American Health Packaging that is covered by recall D-0652-2022 from American Health Packaging. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.