FDA-Drug2018-09-05Class III

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.

Mayne Pharma Inc
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.

Sold states
Nationwide in the USA.
Affected count
6456 bottles
Manufactured in
1240 Sugg Pkwy, N/A, Greenville, NC, United States
Products
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.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1129-2018

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