Drug Recall: Purely Soothing MSM Nasal Spray due to manufacturing deviations
Pharmedica USA is recalling Purely Soothing MSM Nasal Spray (15%, Lot #1808051) due to manufacturing practice violations. The recall affects 995 bottles distributed nationwide and internationally.
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 a voluntary Class II FDA recall with no reported illnesses or injuries. The hazard is a CGMP (manufacturing practice) deviation with no specified acute safety concern. Under the rubric, voluntary precautionary recalls without reported adverse health events are classified as Moderate.
Plain-English summary
Pharmedica USA, LLC initiated a voluntary recall of Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml bottles, on February 14, 2023. The recalled product includes Lot #1808051 with an expiration date of January 1, 2027. A total of 995 bottles were affected by this recall.
The reason for the recall is Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this as a Class II recall. The affected product was distributed nationwide in the United States and worldwide through e-commerce and trade shows.
Consumers should stop using this product. Retailers and distributors should remove affected bottles from sale. Those with questions about the recall should contact Pharmedica USA, LLC.
The recalled product
- Product
- Purely Soothing MSM Nasal Spray, 15%, packaged in 30ml, 1.014 fl. oz bottles, Manufactured by: Pharmedica USA, Phoenix, AZ, UPC 7 31034 91380 5
- Manufacturer
- Pharmedica USA, LLC
- Category
- Drug — Nasal Spray
- Hazard
- Affected units
- 995
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)
- Lot #: 1808051
- Exp.: 01/01/2027
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Pharmedica USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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