Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 9930
Summary
The FDA issued a Class I for Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by by Meta Herbal. Reason: Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil..
Details
Source
Drug Recall
External ID
D-0206-2024
Action Date
2024-01-03
Status
Ongoing
Category
drug
Product Description
Magnum XXL 9800, 2000 mg per capsule, 1 capsule per blister pack, Distributed by Magnum Los Angelas CA. UPC 6 45759 99300 7. Amazon's ASIN# B07P7ZH797, B07P94J3ZT, B07P6VK6N3, B076HNPZZZ
Lot/Code Info: All Lots
Quantity Affected: 500 blister packs
Reason for Recall
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Distribution
Nationwide in the USA. Product was sold via Amazon's Marketplace.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-11-29
Company
East Hampton, NY
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 74 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 (Meta Herbal) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Meta Herbal have FDA actions?
This is the only FDA action we have on record for Meta Herbal in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0206-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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