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 and Baclofen and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
Lot numbers, UPCs & expiration codes
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 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-0606-2020
- 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-0606-2020, 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 and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
- Postal code
- 33634-5339
- Report date
- Dec 18, 2019
- Product type
- Drugs
- Recall number
- D-0606-2020
- 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 and Baclofen and Clonidine HCL and Fentanyl Citrate 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