Healthful Naturals Leg Cramp Support Oral Spray Recalled for CGMP Deviations
Silver Star Brands is recalling Healthful Naturals Leg Cramp Support Oral Spray due to manufacturing deviations that could result in possible 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 2/5 (Moderate).
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 recall is classified as FDA Class II and involves a theoretical risk of microbial contamination without reported illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Silver Star Brands is recalling 247 bottles of Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle. The product is identified by NDC 68703-206-02 and Lot K022216C. 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 source text does not specify specific states or retail locations where the product was sold.
Consumers who have this product should stop using it and contact Silver Star Brands for further instructions or a refund. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Healthful Naturals Leg Cramp Support Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906 NDC 68703-206-02
- 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 K022216C
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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