# FDA recall D-0413-2018

> **ALLERGAN** · Class III · drug recall initiated 2018-02-02.

## Product

NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, 100-count bottles, Rx Only, Distributed by: Allergan USA, Inc., Irvine, CA 92612, NDC 0023-6022-01.

## Reason for recall

Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classification indication on the primary label.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0413-2018
- **Recalling firm:** ALLERGAN
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-02-02
- **Report date:** 2018-02-21
- **Termination date:** 2019-02-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Madison, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0413-2018

## Citation

> AI Analytics. FDA recall D-0413-2018. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0413-2018. Source: US FDA. Licensed CC0.

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