Miss Slim capsules recalled for unapproved marketing distribution
HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules (10-count and 30-count boxes) distributed nationwide in the USA because the product was marketed without required FDA approval (ANDA/NDA).
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: This is an FDA Class II recall of a drug product marketed without required regulatory approval (ANDA/NDA). Class II recalls are classified as Severe per the rubric, as they indicate significant regulatory violations involving unapproved drugs that may pose unknown safety risks.
Plain-English summary
HIS ENTERPRISE INC is recalling all lots of Miss Slim capsules, packaged in both 10-count and 30-count boxes (UPC 742137605030), distributed nationwide throughout the USA. The product is being recalled because it was marketed without the required FDA approval through either an Abbreviated New Drug Application (ANDA) or New Drug Application (NDA).
Consumers who have purchased Miss Slim capsules should stop using the product. Those with questions or concerns should contact HIS ENTERPRISE INC or consult their healthcare provider.
The recalled product
- Product
- Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
- Manufacturer
- HIS ENTERPRISE INC
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
Distribution
Distributed nationwide across the United States.
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