Acetaminophen Child Strawberry Suspension Recalled for Contaminated Excipient
Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml) due to use of a contaminated excipient. The product was manufactured with a recalled ingredient from the excipient 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 with no reported illnesses or injuries. The hazard stems from a manufacturing deviation involving a contaminated excipient, which represents a quality/purity issue rather than a known high-risk pathogen or serious injury threat. This fits the Moderate category for manufacturing-related quality recalls without reported harm.
Plain-English summary
Perrigo Company PLC is recalling Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) bottles, NDC 0363-0971-26, distributed by Walgreen Co. A total of 14,064 bottles have been recalled nationwide.
The recall was initiated because the product was manufactured with a contaminated excipient that had been recalled by the excipient supplier. This represents a deviation from current Good Manufacturing Practice (CGMP) standards.
The affected batches are 1DK0917, 1GK0905, with expiration date 01/31/2023. Consumers who have purchased this product should stop use and consult with a healthcare provider if they have questions about their use of the recalled product.
The recalled product
- Product
- Acetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Pediatric Oral Suspension
- 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 (3)
- Batch: 1DK0917
- 1GK0905
- Exp 01/31/2023
Distribution
Distributed nationwide across the United States.
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