Children's Acetaminophen Oral Suspension Recalled for Contaminated Excipient
Perrigo Company is recalling 561 bottles of Children's Pain & Fever Acetaminophen 160 mg per 5 mL oral suspension due to contamination from a recalled excipient ingredient used during manufacturing.
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 involving a manufacturing deviation (contaminated excipient). The source text does not report any illnesses, injuries, or hospitalizations. The hazard is based on use of a contaminated ingredient supplied by a third party, making this a moderate-severity precautionary recall.
Plain-English summary
Perrigo Company PLC is recalling Children's Pain & Fever Acetaminophen 160 mg per 5 mL oral suspension (UPC: 3 70030 11637 9) distributed nationwide in the United States.
The recall was initiated because the product was manufactured using a contaminated excipient that was itself recalled by the excipient supplier. This represents a deviation from Current Good Manufacturing Practice (CGMP) standards.
The affected product includes batch 1EV1874 with an expiration date of November 2, 2022. A total of 561 bottles are included in this recall.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative pain and fever relief options.
The recalled product
- Product
- Children's Pain & Fever Acetaminophen, 160 mg per 5 mL Oral Suspension combo pack. DS SR APAP 160MG CHLD BBGM/DF CHRY/GRP. UPC: 3 70030 11637 9
- 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: 1EV1874
- Exp 11/02/2022
Distribution
Distributed nationwide across the United States.
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