Silintan herbal pills recalled as Class I for undeclared meloxicam
123Herbals is recalling Silintan 25-count pill bottles because FDA analysis revealed the presence of undeclared meloxicam. The FDA has classified this recall as Class I.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 rubric states an FDA Class I recall is never scored below 4, and this record carries a Class I classification with no reported deaths in the source.
Plain-English summary
Anthony Trinh of 123Herbals LLC is recalling SILINTAN, 25 pills packaged in a 25-count bottle, made by Shanghai Chinese Medical Works of Shanghai, China. The product was distributed nationwide in the United States.
The product was marketed without an approved New Drug Application or Abbreviated New Drug Application, and FDA analysis revealed the presence of undeclared meloxicam. The FDA has classified this recall as Class I, its most serious category.
All lots within expiry are affected.
Consumers can identify affected product by the product name and packaging above, and may contact 123Herbals LLC for further information.
The recalled product
- Product
- SILINTAN 25/pills, packaged in a 25-count bottle, Shanghai Chinese Medical Works, Shanghai, China
- Manufacturer
- ANTHONY TRINH, 123Herbals LLC
- Category
- Drug — Herbal supplement
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)
- All lots within expiry
Distribution
Distributed nationwide across the United States.
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