Hard Steel Capsules packaged in 1 count blister packs in boxes of 10 recall

Why it was recalled

Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.

Details

Product

Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.

Recalling company

Supercore Products Group Inc.

Classification

Class I

Status

Ongoing

Type

Voluntary: Firm initiated

Distribution

Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1)

Initiated

Jul 12, 2024

FDA report date

Oct 9, 2024