Perrigo TopCare Nasal Spray Recalled for Contaminated Excipient
TopCare Nasal Spray (oxymetazoline HCl 0.05%, 1 FL Oz) manufactured by Perrigo Company PLC is being recalled nationwide because the product was made with a contaminated excipient that was itself recalled by the supplier. Consumers should stop using affected batches.
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 control deviation (contaminated excipient) with no reported illnesses or injuries cited in the source text. The hazard is primarily a violation of manufacturing standards rather than a confirmed clinical risk, making this a precautionary recall appropriate for a Moderate severity rating.
Plain-English summary
Perrigo Company PLC is recalling TopCare Nasal Spray, a severe congestion nasal spray containing oxymetazoline hydrochloride 0.05% in 1 FL Oz (30 mL) bottles, distributed nationwide in the USA under NDC 36800-907-10. The recall affects approximately 19,584 bottles from Batch 1BK0716 with an expiration date of 12/31/2022.
The product is being recalled because it was manufactured using a contaminated excipient (an inactive ingredient) that was itself recalled by the excipient supplier. This represents a failure in current Good Manufacturing Practice (CGMP) controls.
Consumers who have purchased this nasal spray should stop using it immediately. Consumers with questions or who may have experienced adverse effects from using this product should contact a healthcare provider or pharmacist. Healthcare professionals and consumers can also report adverse effects to the FDA via MedWatch.
The recalled product
- Product
- TOPCARE NASAL (OXYMETAZOLINE HYDROCHLORIDE)
- Brand
- TOPCARE 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: 1BK0716
- Exp 12/31/2022
Distribution
Distributed nationwide across the United States.
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