Nasal Mist Oxymetazoline HCl Recalled for Contaminated Excipient
Perrigo Company PLC is recalling approximately 64,512 bottles of NASAL MIST oxymetazoline nasal decongestant distributed nationwide because they were manufactured with a contaminated excipient 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 (contaminated excipient). The source text does not report any illnesses, injuries, or hospitalizations related to this defect, and no hazard specificity beyond contamination is stated. The recall is precautionary in nature based on the manufacturing deviation.
Plain-English summary
Perrigo Company PLC is recalling NASAL MIST (Oxymetazoline HCl 0.05% Nasal Decongestant), 1 FL Oz (30 mL) bottles distributed by CVS Pharmacy. Approximately 64,512 bottles with batch number 1FK1164 and expiration date 01/31/2023 are included in this recall. The NDC is 59779-388-10.
The recall was initiated because the products were manufactured using a contaminated excipient that had been recalled by the supplier. This represents a deviation from good manufacturing practice (CGMP).
The affected product was distributed nationwide in the USA. Consumers who have purchased this product should discontinue use and consult their healthcare provider with any questions or concerns.
The recalled product
- Product
- NASAL MIST (OXYMETAZOLINE HCL)
- Brand
- NASAL MIST
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Nasal Decongestant / OTC
- 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: 1FK1164
- Exp 01/31/2023
Distribution
Distributed nationwide across the United States.
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