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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Coast Quality Pharmacy, LLC dba Anazao Health: Compounded Medications Recalled for Potential Fungal Contamination

Agency Publication Date: December 6, 2019
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Summary

Coast Quality Pharmacy, doing business as Anazao Health, is recalling various compounded injectable and intravenous medications, including Clonidine, Morphine Sulfate, and Baclofen, because environmental testing found a fungus called Talaromyces rotundus in the production area. This recall affects 17 units of certain products, while the quantity for others is unknown. These medications were filled and dispensed between late August and early October 2019. Consumers should not use these products and should contact their healthcare provider immediately for alternative treatment.

Risk

The lack of processing controls and the presence of fungus in the sterile environment could lead to serious infections, especially since these medications are often injected or delivered through an IV or pump. No specific injuries have been reported, but contaminated drugs pose a medium risk of infection or systemic illness.

What You Should Do

  1. Check your medication labels for any compounded drugs from AnazaoHealth with a pharmacy address of 5710 Hoover Blvd, Tampa, FL 33634.
  2. Verify if your medication was filled or dispensed between August 26, 2019, and August 29, 2019, or between September 27, 2019, and October 03, 2019.
  3. For Glutamine/Arginine/Carnitine vials, specifically check for those filled and dispensed between September 24, 2019, and September 26, 2019.
  4. Immediately stop using any affected medication and contact your healthcare provider or pharmacist for guidance on alternative medications.
  5. Return any unused product to the place of purchase for a refund and contact Anazao Health at (800) 995-4363 for further instructions.
  6. Report any adverse reactions or quality problems to the FDA MedWatch program at 1-888-SAFEFDA (1-888-723-3332) or online at www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare provider consultation and pharmacy refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Clonidine HCL and Morphine Sulfate
Model:
Recall #: D-0578-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Glutamine/Arginine/Carnitine (17 vials)
Model:
Recall #: D-0579-2020
Lot Numbers:
All lots filled and dispensed 09/24-26/2019 remaining within expiry.
Product: Clonidine HCL/Hydromorphone HCL
Model:
Recall #: D-0580-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Baclofen
Model:
Recall #: D-0581-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Baclofen and Morphine Sulfate
Model:
Recall #: D-0582-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL
Model:
Recall #: D-0583-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate
Model:
Recall #: D-0584-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Bupivacaine HCl and Hydromorphone HCl
Model:
Recall #: D-0585-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Fentanyl Citrate
Model:
Recall #: D-0586-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate
Model:
Recall #: D-0587-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Hydromorphone HCL
Model:
Recall #: D-0588-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Hydromorphone HCL and Bupivacaine HCL
Model:
Recall #: D-0589-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Hydromorphone HCL and Baclofen and Clonidine HCL
Model:
Recall #: D-0590-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Hydromorphone HCL and Clonidine HCL
Model:
Recall #: D-0591-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Morphine Sulfate
Model:
Recall #: D-0592-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Morphine Sulfate and Bupivacaine HCL
Model:
Recall #: D-0593-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Morphine Sulfate and Fentanyl Citrate and Baclofen
Model:
Recall #: D-0594-2020
Lot Numbers:
All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.
Product: Clonidine HCL
Model:
Recall #: D-0595-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Clonidine HCL and Baclofen
Model:
Recall #: D-0596-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Clonidine HCL and Baclofen and Fentanyl Citrate
Model:
Recall #: D-0597-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe
Model:
Recall #: D-0598-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe
Model:
Recall #: D-0599-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Morphine Sulfate and Bupivacaine HCL and Clonidine HCL
Model:
Recall #: D-0600-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL
Model:
Recall #: D-0601-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Baclofen and Clonidine HCL and Morphine Sulfate
Model:
Recall #: D-0602-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen
Model:
Recall #: D-0603-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL
Model:
Recall #: D-0604-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen
Model:
Recall #: D-0605-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL and Fentanyl Citrate
Model:
Recall #: D-0606-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL
Model:
Recall #: D-0607-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Product: Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate
Model:
Recall #: D-0608-2020
Lot Numbers:
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83996
Status: Resolved
Manufacturer: Coast Quality Pharmacy, LLC dba Anazao Health
Sold By: Coast Quality Pharmacy; Anazao Health
Manufactured In: United States
Units Affected: 31 products (Unknown; 17 vials; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown)
Distributed To: Nationwide
Agency Last Updated: December 23, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.