Reported Oct 29, 2014 · Terminated
Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC,…
Bio-pharm, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Bio-pharm, Inc. · 2091 Hartel Ave · Levittown, PA · 19057-4506
Is this the product you have?
- Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle, OTC
- Distributed byRugby 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 LivoniaMI 48150NDC 0904-6308-20
- Lot codes and dates
Lot 3L20Exp. 11/15
- Amount recalled
- 35,739 bottles
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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