Intrathecal Compounding Specialist, LLC recalls All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between Octob…

Recall date

November 30, 2017

Source

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

Recall number

D-0321-2018

FDA classification

Class II

Brand / firm

Intrathecal Compounding Specialist, LLC

Sold / distributed

Nationwide

Why it was recalled

Lack of sterility 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

All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.