SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor
Summary
The FDA issued a Class I for SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack withi by Distributor RFR, LLC.. Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil..
Details
Source
Drug Recall
External ID
D-1333-2022
Action Date
2022-08-10
Status
Terminated
Category
drug
Product Description
SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285
Lot/Code Info: Lot: 48656, Exp. 01/2025
Quantity Affected: 2000 cartons
Reason for Recall
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Distribution
Retail stores in the state of FL, Nationwide in the USA, France and Canada via website sales, and Bolivarian Republic of Venezuela
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-22
Company
Doral, FL
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 29 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
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 (Distributor RFR, LLC.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Distributor RFR, LLC. have FDA actions?
This is the only FDA action we have on record for Distributor RFR, LLC. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1333-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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