Why it was recalled
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Product description
Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
Lot numbers, UPCs & expiration codes
all lots and expirys
Where it was sold
Nationwide
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-0352-2021
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 25, 2021
- FDA report date
- May 5, 2021
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- S & B Story LLC
Original FDA data
Every field from FDA enforcement report D-0352-2021, exactly as published.
Show all FDA fields
- City
- Ridgefield Park
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 87613
- Address
- 30 Railroad Ave
- Code information
- all lots and expirys
- Postal code
- 07660-1347
- Report date
- May 5, 2021
- Product type
- Drugs
- Recall number
- D-0352-2021
- Classification
- Class II
- Recalling firm
- S & B Story LLC
- Reason for recall
- Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 25, 2021
- Initial firm notification
- Press Release
- Center classification date
- Apr 26, 2021