Recalls / Class II
Class IID-0585-2020
Product
Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
- Affected lot / code info
- All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Why it was recalled
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Recalling firm
- Firm
- Coast Quality Pharmacy, LLC dba Anazao Health
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 5710 Hoover Blvd, N/A, Tampa, Florida 33634-5339
Distribution
- Quantity
- Unknown
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2019-09-03
- FDA classified
- 2019-12-06
- Posted by FDA
- 2019-12-18
- Terminated
- 2020-12-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0585-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.