FDA recall D-0237-2021

Product

HUMAN CHORIONIC GONADOTROPIN 1,250 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.

Distribution

Distributed Nationwide in the USA

Key facts

Status

Terminated

Initiation date

2020-11-20

Report date

2021-01-27

Termination date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Miami Lakes, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0237-2021