Class II
Terminated
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,
This recall has been terminated (originally issued October 29, 2014).
- Company
- Bio-Pharm, Inc.
- Recall Initiated
- July 16, 2014
- Posted
- October 29, 2014
- Recall Number
- D-0028-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 35,739 bottles
- Firm Location
- Levittown, PA, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot 3L20, Exp. 11/15
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