# FDA recall D-1129-2018

> **Mayne Pharma Inc** · Class III · drug recall initiated 2018-08-21.

## 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

- **Recall number:** D-1129-2018
- **Recalling firm:** Mayne Pharma Inc
- **Classification:** Class III
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-1129-2018. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-1129-2018. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*