Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, pack...
FDA Recall #D-0654-2020 — Class I — December 17, 2019
Product Description
Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background with silver text, packaged in 2, 4 and 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
8 boxes
Distribution
TX
Code Information
All lots remaining within expiry.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated