Soothing 12 Hour Nasal Decongestant Spray Recall Due to Contaminated Excipient
Perrigo Company PLC is recalling Soothing 12 Hour Nasal Decongestant Spray nationwide because the product was manufactured with a contaminated excipient that was 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: The FDA has classified this as a Class II recall. The source text does not report any illnesses, injuries, or deaths resulting from the contaminated excipient. The recall addresses a manufacturing process deviation (contaminated excipient) without evidence of actual harm, which falls under the "low-risk contamination" criterion for a Moderate severity rating.
Plain-English summary
Perrigo Company PLC is recalling Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) bottles distributed nationwide in the USA. The product is distributed by MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152.
The recall was initiated because the products were manufactured with a contaminated excipient that was recalled from the excipient supplier. This represents a CGMP (Current Good Manufacturing Practice) deviation.
The affected product has NDC 0904-6761-30 and includes batches 1BK0826 (expiring 12/31/2022) and 1FK1164 (expiring 01/31/2023). A total of 41,472 bottles have been distributed.
Consumers who have purchased this product should stop using it and contact Perrigo Company PLC or consult their healthcare provider for guidance.
The recalled product
- Product
- Soothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30
- Manufacturer
- Perrigo Company PLC
- Category
- Drug — Nasal Decongestant Spray
- 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: 1BK0826
- Exp 12/31/2022
- 1FK1164
- Exp 01/31/2023
Distribution
Distributed nationwide across the United States.
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