# FDA recall D-1064-2013

> **Marlex Pharmaceuticals, Inc.** · Class II · drug recall initiated 2013-08-08.

## Product

Acetaminophen Tablets, 500 mg, 100-count bottles, Distributed by: Marlex Pharmaceuticals, Inc., New Castle, DE  19720, List No. 152, NDC 10135-152-01, UPC 3 10135 15201 8.

## Reason for recall

CGMP Deviations: The recalled acetaminophen tablet lot was not manufactured under current good manufacturing practices as noted by a recent inspection of the manufacturing firm.

## Distribution

Nationwide.

## Key facts

- **Recall number:** D-1064-2013
- **Recalling firm:** Marlex Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-08-08
- **Report date:** 2013-10-09
- **Termination date:** 2014-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** New Castle, DE, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1064-2013

## Citation

> AI Analytics. FDA recall D-1064-2013. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1064-2013. Source: US FDA. Licensed CC0.

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