Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram ...

FDA Recall #D-0655-2020 — Class I — December 17, 2019

Recall #D-0655-2020 Date: December 17, 2019 Classification: Class I Status: Terminated

Product Description

Stallion Platinum 30000 Capsules in blue,orange,white background with red,white text in hologram paper packaging, packaged in 2, 4, 10 count blister cards, Motto International, Dallas, TX

Reason for Recall

Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil

Recalling Firm

Motto International Corp — Dallas, TX

Classification

Class I — Reasonable probability of serious adverse health consequences or death.

Product Type

Drugs

Product Quantity

7 boxes

Distribution

TX

Code Information

All lots remaining within expiry.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated