US Drug Recall Register
Class II · Moderate risk Terminated Initiated Apr 17, 2013 (13 years ago)

Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

What was recalled

Mono-mix (Prostaglandin) Injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746

Recalling firm
Axium Healthcare Pharmacy dba Balanced Solutions Compounding
Origin
FL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-281-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.