D-0594-2020 Class II Terminated
FDA drug recall D-0594-2020 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: Unknown.
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
- Unknown
Product Description
Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 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 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.