# FDA recall D-0028-2015

> **Bio-pharm, Inc.** · Class II · drug recall initiated 2014-07-16.

## Product

Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC,   Distributed by: Rugby Laboratories Livonia, MI 48150,  NDC 0536-3606-96    Major Children's Mapap Suspension Liquid, Cherry Flavor,  4 FL OZ bottle, OTC,  Distributed by: Major Pharmaceuticals Livonia, MI 48150 , NDC 0904-6308-20,

## Reason for recall

Superpotent Drug: Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL failure of the product assay at the 6 month timepoint.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0028-2015
- **Recalling firm:** Bio-pharm, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-07-16
- **Report date:** 2014-10-29
- **Termination date:** 2015-08-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Levittown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0028-2015

## Citation

> AI Analytics. FDA recall D-0028-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0028-2015. Source: US FDA. Licensed CC0.

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