Hydroxyprogesterone Caproate 350mg/ml recalled over sterility concerns

Recall date

March 26, 2020

Source

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

Official notice title

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy recalls Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EAST…

Recall number

D-1097-2020

FDA classification

Class II

Brand / firm

Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy

Sold / distributed

Patient Distribution list includes addresses in the following states: CA, ME, TX

Why it was recalled

Lack of Assurance of Sterility

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

What was recalled

Hydroxyprogesterone Caproate (BUD) 350mg/ml , 4 mL, Injectable, Rx only, INNOVATIVE COMPOUNDING PHARMACY, 41536 EASTMAN DRIVE SUITE A MURRIETA , CA 92562 951-304-9530