Class II
Terminated
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
This recall has been terminated (originally issued December 18, 2019).
- Recall Initiated
- September 3, 2019
- Posted
- December 18, 2019
- Recall Number
- D-0584-2020
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- Unknown
- Firm Location
- Tampa, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Distribution
Nationwide in the U.S.
Lot / Code Info
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
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