Mayne Pharma Recalls Oxycodone and Acetaminophen Tablets Due to Labeling Error
Mayne Pharma is recalling 6,456 bottles of Oxycodone and Acetaminophen Tablets due to a lot number labeling error on the primary container.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a documentation/labeling error regarding the lot number, not a product safety defect.
Plain-English summary
Mayne Pharma Inc is voluntarily recalling 6,456 bottles of Oxycodone and Acetaminophen Tablets, USP, 5 mg/325 mg, 100-count. The recall is due to a labeling error where the primary container displays the incorrect lot number FG01517, while the shipper labels and invoices correctly list the lot number as FG10517. The affected products have an expiration date of 12/31/2019.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. The error is limited to the lot number printed on the bottle and does not indicate a problem with the medication itself.
Consumers and healthcare providers with these specific bottles should stop using them and contact their pharmacist or Mayne Pharma for instructions on how to return the product. The affected lot is FG10517, which is mislabeled as FG01517 on the bottle.
The recalled product
- Product
- Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC 68308-841-01.
- Manufacturer
- Mayne Pharma Inc
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 6,456
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: FG01517
- Exp. 12/31/2019
Distribution
Distributed nationwide across the United States.
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