Bio-Pharm Recalls Acetaminophen Oral Suspension Due to Assay Failure
Bio-Pharm, Inc. is recalling one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL because the product failed the assay at the 6-month timepoint.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any illnesses or injuries, and the hazard is a failure of the product assay rather than a high-risk pathogen or structural defect.
Plain-English summary
Bio-Pharm, Inc. is initiating a recall of one lot of Acetaminophen Oral Suspension Liquid 160mg/5mL. The recall is being conducted because the product failed the assay at the 6-month timepoint.
The affected product is identified as Lot 3L20 with an expiration date of 11/15. The recall covers 35,739 bottles distributed nationwide. The product is available as Rugby Children's Pain and Fever Acetaminophen Oral Suspension 160 mg/5 mL, Cherry Flavor, 2 FL. oz bottle (NDC 0536-3606-96) and Major Children's Mapap Suspension Liquid, Cherry Flavor, 4 FL OZ bottle (NDC 0904-6308-20).
Consumers should check their inventory for the specific lot number and expiration date listed above. If the product matches the recalled lot, consumers should stop using it and contact the manufacturer or their healthcare provider for further instructions.
The recalled product
- 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
- Manufacturer
- Bio-pharm, Inc.
- Hazard
- Affected units
- 35,739
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 3L20
- Exp. 11/15
Distribution
Distributed nationwide across the United States.
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