D-0606-2020 Class II Terminated
FDA drug recall D-0606-2020 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
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate 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 and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.