Drug product
Imperial Extreme 2000 Capsules, 2000 mg, 1 count blister cards, distributed S&B Shopper LLC. Little Ferry, NJ UPC 7 18122 04073 5
D-0352-2021
Product summary
- Firm
- S & B Story LLC
- Event
- Event 87613
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0352-2021
Official wording
Reason: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Code information: all lots and expirys
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.