Why it was recalled
Marketed without an approved NDA/ANDA: Magnum XXL found to contain undeclared active pharmaceutical ingredient (API) - Sildenafil.
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 numbers, UPCs & expiration codes
All Lots
Where it was sold
Nationwide in the USA. Product was sold via Amazon's Marketplace.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0206-2024
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- Nov 29, 2023
- FDA report date
- Jan 3, 2024
- Quantity
- 500 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Meta Herbal
Original FDA data
Every field from FDA enforcement report D-0206-2024, exactly as published.
Show all FDA fields
- City
- East Hampton
- State
- NY
- Status
- Ongoing
- Country
- United States
- Event ID
- 93510
- Address
- 33 Cordwood Ln
- Code information
- All Lots
- Postal code
- 11937-5201
- Report date
- Jan 3, 2024
- Product type
- Drugs
- Recall number
- D-0206-2024
- Classification
- Class I
- Recalling firm
- Meta Herbal
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA. Product was sold via Amazon's Marketplace.
- Recall initiation date
- Nov 29, 2023
- Initial firm notification
- Press Release
- Center classification date
- Dec 27, 2023