FDA-Drug2014-10-29Class II

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,

Bio-pharm, Inc.
Hazard

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.

Sold states
Nationwide
Affected count
35,739 bottles
Manufactured in
2091 Hartel Ave, Levittown, PA, United States
Products
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,

Official notice

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

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