Drug product
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.
D-1129-2018
Product summary
- Firm
- Mayne Pharma Inc
- Event
- Event 80833
- Status
- Terminated
- Classification
- Class III
- Quantity
- 6456 bottles
- Official record key
drug-enforcement:D-1129-2018
Official wording
Reason: 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.
Code information: Lot: FG01517, Exp. 12/31/2019
Distribution pattern: Nationwide in the USA.
Derived failure modes
-
Labeling or packaging
mislabeled