CareOne Severe Congestion Nasal Spray Recalled for Contaminated Excipient
Perrigo Company is recalling CareOne Severe Congestion Nasal Spray due to contaminated excipient used during manufacturing. The nasal spray was made with an 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 involving a manufacturing deviation with a contaminated excipient. The source does not report any illnesses, injuries, or hospitalizations. No specific hazard beyond the general manufacturing deviation is detailed in the source text.
Plain-English summary
Perrigo Company PLC is recalling CareOne Severe Congestion Nasal Spray (Oxymetazoline HCl 0.05%, 1 FL Oz per bottle) distributed nationwide in the USA. The recall affects approximately 7,200 bottles.
The products were manufactured using a contaminated excipient that had been recalled by the excipient supplier. This represents a deviation from good manufacturing practices (CGMP).
Affected lots are Batch 1BK0716 (expiration 12/31/2022) and Batch 1FK1251 (expiration 02/28/2023), with NDC 41520-108-10. Consumers who have purchased this product should stop using it and consult with their healthcare provider if they have concerns.
The recalled product
- Product
- CAREONE SEVERE CONGESTION NASAL (OXYMETAZOLINE HYDROCHLORIDE)
- Brand
- CAREONE SEVERE CONGESTION NASAL
- 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 (4)
- Batch: 1BK0716
- Exp 12/31/2022
- 1FK1251
- Exp 02/28/2023
Distribution
Distributed nationwide across the United States.
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Same brand · CAREONE SEVERE CONGESTION NASAL
- ModerateCareOne Severe Congestion Nasal Spray Recalled Due to Contaminated Excipient
FDA (Drugs) · 2022-03-02
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