Reported Sep 5, 2018 · Terminated

Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma,…

Mayne Pharma Inc.

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Mayne Pharma Inc · 1240 Sugg Pkwy · Greenville, NC · 27834-9006

Is this the product you have?

  • Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only
  • Manufactured byMayne Pharma, Greenville, NC 27834, NDC 68308-841-01
Lot codes and dates
  • Lot
    • FG01517
    • Exp. 12/31/2019
Amount recalled
6456 bottles

Where it was sold

  • Nationwide

Why it was recalled

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.

This product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 19, 2020 · Data as of Sep 19, 5:02 PM UTC

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