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Pain Tablets Pulled


September 07, 2018

Mayne Pharma Inc. issued a voluntary recall for a single lot of 100-count bottles of oxycodone and acetaminophen tablets, USP, 5 mg/325 mg (NDC 68308-841-01), according to the September 5, 2018, US Food and Drug Administration (FDA) Enforcement Report.

A labeling mix-up prompted the recall. According to the FDA, the recalled product’s lot number — FG10517 — is mislabeled on the primary container as FG01517. Shipper labels and invoices, however, contain the correct lot number, FG10517. The lot expires December 31, 2019.

Bottles from the affected lot were distributed throughout the United States.

Mayne Pharma initiated the recall August 21, 2018. On August 28, 2018, the FDA designated the recall Class III, signaling use of the affected product is not likely to cause harm.

Oxycodone and acetaminophen tablets are available with a prescription for the relief of moderate to moderately severe pain.

Jolynn Tumolo


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