TOPCARE NASAL Oxymetazoline HCl Recalled Due to Contaminated Excipient
Perrigo Company PLC is recalling TOPCARE NASAL (Oxymetazoline HCl 0.05%) nasal spray nationwide because products were manufactured with a contaminated excipient obtained from a supplier whose material was recalled.
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 hospitalizations. This is a precautionary manufacturing defect recall.
Plain-English summary
Perrigo Company PLC is recalling TOPCARE NASAL No Drip Nasal Spray (Oxymetazoline HCl 0.05%, 1 FL Oz bottles) distributed by TOPCO ASSOCIATES LLC nationwide. The recall affects 13,824 bottles with Batch 1FK1233 and expiration date 01/31/2023 (NDC 36800-388-10).
The products were manufactured with a contaminated excipient—an inactive ingredient—that was obtained from a supplier whose material had been recalled. This is a Current Good Manufacturing Practice (CGMP) deviation.
Consumers who have purchased this product should stop using it. Anyone with questions or concerns should contact their healthcare provider or pharmacist.
The recalled product
- Product
- TOPCARE NASAL (OXYMETAZOLINE HCL)
- Brand
- TOPCARE NASAL
- 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: 1FK1233
- Exp 01/31/2023
Distribution
Distributed nationwide across the United States.
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