Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
Summary
The FDA issued a Class II for Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His by HIS ENTERPRISE INC. Reason: Marketed without ANDA/NDA approval.
Details
Source
Drug Recall
External ID
D-0770-2021
Action Date
2021-09-01
Status
Ongoing
Category
drug
Product Description
Miss Slim, capsules, packaged in 10-count and 30-count box, Distributed by : His Enterprise Made in USA UPC 742137605030
Lot/Code Info: all lots
Quantity Affected: N/A
Reason for Recall
Marketed without ANDA/NDA approval
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-07-20
Company
Palisades Park, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 58 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (HIS ENTERPRISE INC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does HIS ENTERPRISE INC have FDA actions?
This is the only FDA action we have on record for HIS ENTERPRISE INC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0770-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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