Drug Enforcement D-0206-2024

Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.

Status

Ongoing

Classification

Class I

Report Date

January 3, 2024

Termination Date

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Product Information

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
Product quantity
500 blister packs
Reason for recall
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
Recall initiation reason
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Initial firm notification
Press Release
Distribution pattern
Nationwide in the USA. Product was sold via Amazon's Marketplace.

Location & Firm

Recalling firm
Meta Herbal
Address
33 Cordwood Ln

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0206-2024
Event ID
93510
Recall initiation date
November 29, 2023
Center classification date
December 27, 2023
Code info
All Lots
More code info
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