Nasal Oxymetazoline Spray Recalled for Contaminated Excipient
Perrigo Company is recalling approximately 9,888 bottles of NASAL Severe Congestion Nasal Spray due to contamination from a recalled excipient used during manufacturing. The product was distributed nationwide.
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: The FDA classified this as a Class II recall. The source text identifies a CGMP deviation involving a contaminated excipient but does not report any illnesses, injuries, or deaths. The recall is precautionary in nature.
Plain-English summary
Perrigo Company PLC is recalling approximately 9,888 bottles of NASAL Severe Congestion Nasal Spray (Oxymetazoline HCl 0.05%, No Drip Plus Menthol, 1 FL Oz / 30 mL, NDC 11822-6378-1). The recall affects product with Batch 11BK0827 and expiration date 12/31/2022.
The recall was initiated due to current good manufacturing practices (CGMP) deviations. The product was manufactured using a contaminated excipient—an inactive ingredient—that had been recalled by the excipient supplier.
The affected product was distributed nationwide in the USA and was distributed by Rite Aid. Consumers who have purchased this product should stop using it and consult a healthcare provider with any questions or concerns about prior use.
The recalled product
- Product
- NASAL (OXYMETAZOLINE HYDROCHLORIDE)
- Brand
- 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 (2)
- Batch: 11BK0827
- Exp 12/31/2022
Distribution
Distributed nationwide across the United States.
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