FDAFDA · Food and drugs·Recall number D-1129-2018
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.
Published September 5, 2018 · Recall initiated: August 21, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Labeling: Incorrect or Missing Lot and/or Exp Date: Lot FG10517 is mislabeled on the primary container with Lot FG01517, shipper labels and invoices contain the correct lot number of FG10517.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mayne Pharma Inc
- Distributor
- Nationwide in the USA.
- Lot
- Lot: FG01517, Exp. 12/31/2019
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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