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Recall Observatory FDA recall evidence

Drug product

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

D-0206-2024

November 29, 2023

Class I

Product summary

Firm
Meta Herbal
Event
Event 93510
Status
Ongoing
Classification
Class I
Quantity
500 blister packs
Official record key
drug-enforcement:D-0206-2024

Official wording

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

Code information: All Lots

Distribution pattern: Nationwide in the USA. Product was sold via Amazon's Marketplace.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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