Recalls / Class III
Class IIID-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.
- Affected lot / code info
- Lot: FG01517, Exp. 12/31/2019
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.
Recalling firm
- Firm
- Mayne Pharma Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1240 Sugg Pkwy, N/A, Greenville, North Carolina 27834-9006
Distribution
- Quantity
- 6456 bottles
- Distribution pattern
- Nationwide in the USA.
Timeline
- Recall initiated
- 2018-08-21
- FDA classified
- 2018-08-28
- Posted by FDA
- 2018-09-05
- Terminated
- 2020-05-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1129-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.