Why it was recalled
Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
Product description
UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.
Lot numbers, UPCs & expiration codes
All lots
Where it was sold
Nationwide in the USA
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-1036-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 8, 2019
- FDA report date
- Mar 25, 2020
- Quantity
- 1,680 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Med Man Distribution, Inc.
Original FDA data
Every field from FDA enforcement report D-1036-2020, exactly as published.
Show all FDA fields
- City
- Pickerel
- Status
- Terminated
- Country
- Canada
- Event ID
- 84265
- Address
- 433 Pickerel River Rd
- Code information
- All lots
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1036-2020
- Classification
- Class I
- Recalling firm
- Med Man Distribution, Inc.
- Product quantity
- 1,680 cartons
- Termination date
- Oct 17, 2023
- Reason for recall
- Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Nov 8, 2019
- Initial firm notification
- Press Release
- Center classification date
- Mar 19, 2020