D-0600-2020 Class II Terminated
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 Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363
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.