FDA recall D-1129-2018

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.

Reason for recall

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.

Distribution

Nationwide in the USA.

Key facts

Status

Terminated

Initiation date

2018-08-21

Report date

2018-09-05

Termination date

2020-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Greenville, NC, United States

Primary source

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