HUMAN CHORIONIC GONADOTROPIN 5 recalled over manufacturing violations

Recall date

November 20, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Complete Pharmacy and Medical Solutions, LLC. recalls HUMAN CHORIONIC GONADOTROPIN 5,000 IU per vial Aso contains Mannitol 9%, Sodium Phosphate 2% in water for injection. Ly…

Recall number

D-0236-2021

FDA classification

Class II

Brand / firm

Complete Pharmacy and Medical Solutions, LLC.

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

CGMP deviations: Lack of potency testing.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HUMAN CHORIONIC GONADOTROPIN 5,000 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