July 2021 FDA Recall Drug by His Enterprise Inc
D-0770-2021 - Marketed without ANDA/NDA approval

This Class II drug recall was voluntarily initiated by His Enterprise Inc on July 20, 2021 for the product Drug. The FDA reported the reason for recall as marketed without anda/nda approval. The product was distributed Nationwide and the recall is currently ongoing.

Recall Number: D-0770-2021

Reason for Recall
Marketed without ANDA/NDA approval
Initiated
07-20-2021
Reported
09-01-2021
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
88303
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
HIS ENTERPRISE INC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
USA nationwide.
Product Description About Product Description
Full technical description of the product.
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030

Batch or Lot Expiration Information

Lot# all lots