D-0352-2021 Class II Ongoing
FDA drug recall D-0352-2021 was initiated by S & B Story LLC on March 25, 2021 and is designated Class II. Reason for recall: Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil. The recall status is ongoing. Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- May 5, 2021
- Initiation Date
- March 25, 2021
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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
Reason for Recall
Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.
Distribution Pattern
Nationwide
Code Information
all lots and expirys