HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in w...
FDA Recall #D-0235-2021 — Class II — November 20, 2020
Product Description
HUMAN CHORIONIC GONADOTROPIN 6,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Lyophilized, Unpreserved. Complete Pharmacy & Medical Solutions 5829 NW 158th St, Miami Lakes, FL 33014 Tel: 305-397-2035
Reason for Recall
CGMP deviations: Lack of potency testing.
Recalling Firm
Complete Pharmacy and Medical Solutions, LLC. — Miami Lakes, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2418 vials
Distribution
Distributed Nationwide in the USA
Code Information
Lot# 40604 Use By date, 01/30/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated