D-0579-2020 Class II Terminated
FDA drug recall D-0579-2020 was initiated by Coast Quality Pharmacy, LLC dba Anazao Health on September 3, 2019 and is designated Class II. Reason for recall: Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi. The recall status is terminated (terminated December 1, 2020). Affected quantity: 17 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2019
- Initiation Date
- September 3, 2019
- Termination Date
- December 1, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17 vials
Product Description
Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.
Reason for Recall
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Distribution Pattern
Nationwide in the U.S.
Code Information
All lots filled and dispensed 09/24-26/2019 remaining within expiry.