Recall Register

Drug recall: Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa…

Class II FDA enforcement event 83996. Recall start date: . Status in the FDA record: Terminated. Termination date: .

Reason for recall, in the words of FDA

Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Coast Quality Pharmacy, LLC dba Anazao Health started this drug recall on 3 Sep 2019. The firm address in the FDA record is in Tampa, FL. FDA put the recall in Class II. FDA event 83996 has 31 product records. The first FDA enforcement report date is 18 Dec 2019. The record gives the status Terminated, with the termination date 1 Dec 2020.

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.

FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .

Distribution

In the words of FDA.

Nationwide in the U.S.

Recalling firm

Coast Quality Pharmacy, LLC dba Anazao Health, Tampa, FL.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

31 product records in the event.

FDA event 83996: product records
Recall numberProductQuantityClassStatusReport date
D-0578-2020Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0579-2020Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.17 vialsClass IITerminated18 Dec 2019
D-0580-2020Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0581-2020Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0582-2020Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0583-2020Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0584-2020Bupivacaine 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.UnknownClass IITerminated18 Dec 2019
D-0585-2020Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0586-2020Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0587-2020Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0588-2020Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0589-2020Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0590-2020Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0591-2020Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0592-2020Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0593-2020Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0594-2020Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0595-2020Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0596-2020Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0597-2020Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0598-2020Clonidine HCL PF 750 mcg/mL/Prialt PF (vial) 55 mcg/mL/Bupivacaine HCL PF 24 mg/mL *Compounded 20 mL Syringe (Standard) AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363UnknownClass IITerminated18 Dec 2019
D-0599-2020Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL PF 12.8 mg/mL, Compounded, 20 mL Syringe, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0600-2020Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363UnknownClass IITerminated18 Dec 2019
D-0601-2020Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0602-2020Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0603-2020Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0604-2020Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0605-2020Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0606-2020Hydromorphone 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.UnknownClass IITerminated18 Dec 2019
D-0607-2020Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019
D-0608-2020Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.UnknownClass IITerminated18 Dec 2019

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2019
362
Share of these events in Class II
68%
Product records in this event
31Median of the firm: 31
Events of the firm on the register
2

Other events of the firm

Other FDA enforcement events of Coast Quality Pharmacy, LLC dba Anazao Health
InitiatedProduct (first record)TypeClassRecords
24 Apr 2024Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly, AnazaoHealth, Event 94691DrugClass II1

Official channels

Cite this page

Recall Register. FDA enforcement event 83996. https://recallregister.com/fda/ii/83996/. Source: openFDA enforcement reports. Data through .

Sources

Source
openFDA drug enforcement reports
Licence
CC0 1.0
Export date
28 Sep 2026
Newest FDA report date on the register
23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?
The FDA record gives this distribution: Nationwide in the U.S.
What quantity of product is in FDA event 83996?
The event has 31 product records. The first record gives this quantity: Unknown
How did the recall start?
The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2019 have the same class?
68% of the 362 drug events that started in 2019 are in Class II.