Oxycodone and Acetaminophen Tablets recalled over labeling errors

Recall date

August 21, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

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

Recall number

D-1129-2018

FDA classification

Class III

Brand / firm

Mayne Pharma Inc

Sold / distributed

Nationwide in the USA.

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.