CLASS II Drug recall · Reported 18 Dec 2019 · FDA Enforcement Report
Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL recalled
Coast Quality Pharmacy is recalling Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all, distributed nationwide in the US. The recall was initiated on 3 Sep 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0584-2020
- FDA event ID
- 83996
- Recalling firm
- Coast Quality Pharmacy, Tampa, FL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Sep 2019
- FDA classified
- 6 Dec 2019
- Reported
- 18 Dec 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Packaging Defects
- Drug class
- Blood Pressure Medication
Timeline
| 3 Sep 2019 | Recall initiated by company | |
| 6 Dec 2019 | Classified by FDA | +94 days |
| 18 Dec 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Is Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all recalled?
Yes. Coast Quality Pharmacy recalled Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL and Fentanyl Citrate in all on 3 Sep 2019. The recall is Class II and its status is Terminated. Recall number D-0584-2020.
Why was it recalled?
Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Which lots are affected?
All lots filled and dispensed on 08/26-29/2019 and 09/27/2019 through 10/03/2019 remaining within expiry.
Where was it sold?
Nationwide in the U.S.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Coast Quality Pharmacy
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Progesterone 200 mg, Compounded, Rx recalled by Coast Quality Pharmacy | Coast Quality Pharmacy | Foreign Material | Nationwide |
| Drug | CLASS II | Clonidine HCL and Baclofen and Fentanyl Citrate recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |
| Drug | CLASS II | Fentanyl Citrate in all strengths, all doses recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |
| Drug | CLASS II | Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF recalled | Coast Quality Pharmacy | Other | Nationwide |
| Drug | CLASS II | Hydromorphone HCL and Clonidine HCL in all strengths recalled | Coast Quality Pharmacy | Packaging Defects | Nationwide |