PROSTAGLANDIN PGE-1 40MCG/ML recalled over sterility concerns

Recall date

October 6, 2015

Source

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

Official notice title

Chen Shwezin, Inc. dba Park Compounding Pharmacy recalls PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Vi…

Recall number

D-0156-2016

FDA classification

Class II

Brand / firm

Chen Shwezin, Inc. dba Park Compounding Pharmacy

Sold / distributed

CA

Why it was recalled

Lack of Assurance of Sterility: all sterile compounded products within expiry

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

What was recalled

PROSTAGLANDIN PGE-1 40MCG/ML, 10mL vial, Rx only, Park Compounding Pharmacy 280 N. Westlake Blvd., Ste. 100 Westlake Village, CA 91362, (805) 497-8258