17-HP Hydroxyprogesterone 250mg/ Injection recalled over sterility concerns

Recall date

February 12, 2015

Source

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

Official notice title

Health Innovations Pharmacy, Inc recalls 17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910…

Recall number

D-0998-2015

FDA classification

Class II

Brand / firm

Health Innovations Pharmacy, Inc

Sold / distributed

NC

Why it was recalled

Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

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

What was recalled

17-HP Hydroxyprogesterone 250mg/1ml Injection, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155