FDA Drug Class II — Moderate

Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

Hazard

Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Products

Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Brand
Coast Quality Pharmacy, LLC dba Anazao Health
UPC
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Units Affected

Unknown