Why it was recalled
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Product description
Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lot numbers, UPCs & expiration codes
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Where it was sold
Nationwide in the U.S.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0589-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 3, 2019
- FDA report date
- Dec 18, 2019
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Coast Quality Pharmacy, LLC dba Anazao Health
Original FDA data
Every field from FDA enforcement report D-0589-2020, exactly as published.
Show all FDA fields
- City
- Tampa
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 83996
- Address
- 5710 Hoover Blvd
- Code information
- All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
- Postal code
- 33634-5339
- Report date
- Dec 18, 2019
- Product type
- Drugs
- Recall number
- D-0589-2020
- Classification
- Class II
- Recalling firm
- Coast Quality Pharmacy, LLC dba Anazao Health
- Product quantity
- Unknown
- Termination date
- Dec 1, 2020
- Reason for recall
- Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
- Distribution pattern
- Nationwide in the U.S.
- Recall initiation date
- Sep 3, 2019
- Initial firm notification
- Telephone
- Center classification date
- Dec 6, 2019