Rugby Children's Acetaminophen Oral Suspension Recalled for Contaminated Excipient
Perrigo Company PLC is recalling Rugby Children's Acetaminophen Oral Suspension (160mg/5ml) because the product was manufactured with a contaminated excipient that had been recalled from the supplier.
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: This is an FDA Class II recall. The source text does not report any illnesses, injuries, or deaths associated with the contaminated excipient. The recall is precautionary in nature, based on a manufacturing deviation with a contaminated ingredient from the supplier.
Plain-English summary
Perrigo Company PLC is recalling Rugby Children's Acetaminophen (Acetaminophen) Children's Grape Flavored Oral Suspension, 160mg/5ml, 4 FL OZ (118 mL) bottles, NDC 0536-1321-97, Batch 1BK0960, expiration date 12/31/2022. The product was manufactured using a contaminated excipient that was itself recalled by the excipient supplier, representing a deviation from good manufacturing practices.
The affected product was distributed nationwide in the USA. Approximately 4,992 bottles are subject to this recall.
Consumers who have purchased this product should stop using it and consult their healthcare provider or pharmacist for guidance. The product should not be used, particularly in children.
The recalled product
- Product
- RUGBY CHILDRENS ACETAMINOPHEN (ACETAMINOPHEN)
- Brand
- RUGBY CHILDRENS ACETAMINOPHEN
- Manufacturer
- Perrigo Company PLC
- Hazard
- contaminated-excipient
- cgmp-deviation
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)
- Batch: 1BK0960
- Exp 12/31/2022
Distribution
Distributed nationwide across the United States.
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