PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: January 27, 2021 Initiated: November 20, 2020 #D-0236-2021

Product Description

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

Reason for Recall

CGMP deviations: Lack of potency testing.

Details

Units Affected
1144 vials
Distribution
Distributed Nationwide in the USA
Location
Miami Lakes, FL

Frequently Asked Questions

What product 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. Recalled by Complete Pharmacy and Medical Solutions, LLC.. Units affected: 1144 vials.
Why was this product recalled?
CGMP deviations: Lack of potency testing.
Which agency issued this recall?
This recall was issued by the FDA Drug on January 27, 2021. Severity: Moderate. Recall number: D-0236-2021.