FDAClass IIISeptember 5, 2018

Oxycodone and Acetaminophen Tablets recall: Labeling Error

Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC…

Why was Oxycodone and Acetaminophen Tablets 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot: FG01517, Exp. 12/31/2019

Product
Oxycodone and Acetaminophen Tablets, USP, 5 mg*/325 mg, 100-count bottle, Rx Only, Manufactured by: Mayne Pharma, Greenville, NC 27834, NDC…
Recalling firm
Mayne Pharma Inc
Quantity
6456 bottles
Distribution
Nationwide in the USA.
Recall date
September 5, 2018
Classification
Class III
Status
Terminated
Agency
FDA (drug)
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