D-0352-2021 Class II Ongoing

Recalled by S & B Story LLC — Ridgefield Park, NJ

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