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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83996

31 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
September 03, 2019
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Coast Quality Pharmacy, LLC dba Anazao Health

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

31 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 31

Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0578-2020
Recall number
D-0578-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 2 of 31

Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.

D-0579-2020
Recall number
D-0579-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
17 vials

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed 09/24-26/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 3 of 31

Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0580-2020
Recall number
D-0580-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 4 of 31

Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0581-2020
Recall number
D-0581-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 5 of 31

Baclofen and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0582-2020
Recall number
D-0582-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 6 of 31

Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0583-2020
Recall number
D-0583-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 7 of 31

Bupivacaine 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.

D-0584-2020
Recall number
D-0584-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 8 of 31

Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0585-2020
Recall number
D-0585-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 9 of 31

Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0586-2020
Recall number
D-0586-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 10 of 31

Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0587-2020
Recall number
D-0587-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 11 of 31

Hydromorphone HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0588-2020
Recall number
D-0588-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 12 of 31

Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0589-2020
Recall number
D-0589-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 13 of 31

Hydromorphone HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0590-2020
Recall number
D-0590-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 14 of 31

Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0591-2020
Recall number
D-0591-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 15 of 31

Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0592-2020
Recall number
D-0592-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 16 of 31

Morphine Sulfate and Bupivacaine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0593-2020
Recall number
D-0593-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 17 of 31

Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0594-2020
Recall number
D-0594-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 18 of 31

Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0595-2020
Recall number
D-0595-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 19 of 31

Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0596-2020
Recall number
D-0596-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 20 of 31

Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0597-2020
Recall number
D-0597-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 21 of 31

Clonidine 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) 995-4363

D-0598-2020
Recall number
D-0598-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 22 of 31

Sufentanil 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.

D-0599-2020
Recall number
D-0599-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 23 of 31

Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634 (800) 995-4363

D-0600-2020
Recall number
D-0600-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 24 of 31

Morphine Sulfate and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0601-2020
Recall number
D-0601-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 25 of 31

Baclofen and Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0602-2020
Recall number
D-0602-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 26 of 31

Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0603-2020
Recall number
D-0603-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 27 of 31

Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0604-2020
Recall number
D-0604-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 28 of 31

Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and Baclofen in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0605-2020
Recall number
D-0605-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 29 of 31

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.

D-0606-2020
Recall number
D-0606-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 30 of 31

Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0607-2020
Recall number
D-0607-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

drug · product 31 of 31

Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

D-0608-2020
Recall number
D-0608-2020
Initiated
September 03, 2019
Classification
Class II
Status
Terminated
Quantity
Unknown

App-derived interpretation

Manufacturing or process control reason.manufacturing_process_control · v1.0.0
Lack of Processing Controls

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

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

Code information

All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.

Distribution pattern

Nationwide in the U.S.

Field note

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