Silver Star Brands Recalls DizziFree Oral Spray Due to CGMP Deviations
Silver Star Brands is recalling 247 bottles of Healthful Naturals DizziFree Oral Spray due to manufacturing deviations that could result in microbial contamination.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall with potential for significant injury (microbial contamination) maps to a severity score of 4 (Severe), as it is not a Class I recall but involves a significant health hazard.
Plain-English summary
Silver Star Brands is recalling 247 bottles of Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle. The product is identified by Lot K022616D and NDC 68703-204-02. The recall was initiated because the product was manufactured by a contract manufacturer under conditions that deviated from Current Good Manufacturing Practices (CGMP), which could result in possible microbial contamination.
The affected product was distributed nationwide in the United States. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have purchased this product should stop using it and contact Silver Star Brands for further instructions or a refund. The recall is limited to the specific lot number and quantity listed above.
The recalled product
- Product
- Healthful Naturals DizziFree Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-204-02
- Manufacturer
- Silver Star Brands
- Category
- Drug — Oral Spray
- Hazard
- Affected units
- 247
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 (1)
- Lot K022616D
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Silver Star Brands 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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