Signature Care Nasal Decongestant Recalled Due to Contaminated Excipient
Perrigo Company PLC is recalling Signature Care Nasal Decongestant (Oxymetazoline HCl 0.05%) nationwide due to contamination from a recalled excipient used in manufacturing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 (CGMP deviation). The source text does not report any illnesses, injuries, or specific health hazards from the contaminated excipient itself—only that the excipient was recalled. In the absence of reported harm or a high-risk pathogen, a manufacturing deviation with a contaminated but unspecified excipient qualifies as Moderate.
Plain-English summary
Perrigo Company PLC, distributed by Better Living Brands LLC, is recalling Signature Care No Drip Nasal Decongestant (Oxymetazoline HCl 0.05%, 1 FL Oz/30 mL bottles) nationwide. The recall affects 11,088 bottles manufactured under Batch 1BK0964 with expiration date 01/31/2023 (NDC 21130-801-10).
The product was manufactured using a contaminated excipient that was subsequently recalled by the excipient supplier. This represents a deviation from Current Good Manufacturing Practice (CGMP) standards.
Consumers who have purchased this product should stop using it and consult with a healthcare provider or pharmacist with questions about safe alternatives. The recalling firm and regulatory agencies are working to ensure affected product is removed from distribution.
The recalled product
- Product
- SIGNATURE CARE NASAL DECONGESTANT (OXYMETAZOLINE HCL)
- Brand
- SIGNATURE CARE NASAL DECONGESTANT
- Manufacturer
- Perrigo Company PLC
- Affected units
- 11,088
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: 1BK0964
- Exp 01/31/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 51 recalled by Perrigo Company PLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 51 products in this recall →Related recalls
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