# FDA recall D-919-2013

> **Advance Pharmaceutical Inc** · Class I · drug recall initiated 2013-06-17.

## Product

ENTERIC COATED ASPIRIN (NSAID), 81 mg, 120-count tablets per bottle, distributed by: Rugby Laboratories, Inc., Duluth, Georgia 30097, NDC 0536-3086-41, UPC 3 0536-3086-41 9.

## Reason for recall

Labeling: Label Mix-Up: A complaint from a pharmacist was received that the entire contents of 1 bottle labeled as Rugby label Enteric Coated Aspirin 81 mg Tablets actually contained Acetaminophen 500 mg Tablets.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-919-2013
- **Recalling firm:** Advance Pharmaceutical Inc
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-06-17
- **Report date:** 2013-09-04
- **Termination date:** 2016-05-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Holtsville, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-919-2013

## Citation

> AI Analytics. FDA recall D-919-2013. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-919-2013. Source: US FDA. Licensed CC0.

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