D-1129-2018 Class III Terminated
FDA drug recall D-1129-2018 was initiated by Mayne Pharma Inc on Aug 21, 2018 and is designated Class III. 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. The recall status is terminated (terminated May 19, 2020). Affected quantity: 6456 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Sep 5, 2018
- Initiation Date
- Aug 21, 2018
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6456 bottles
Product Description
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 Pattern
Nationwide in the USA.
Code Information
Lot: FG01517, Exp. 12/31/2019
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1129-2018
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026