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
FG01517Exp. 12/31/2019
- Lot
- 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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