CLASS II Drug recall · Reported 18 Dec 2019 · FDA Enforcement Report

Bupivacaine HCl and Hydromorphone HCl in all strengths recalled

Coast Quality Pharmacy is recalling Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all packaging, 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

Lot, batch or date codesAll lots filled 08/26/2019 and dispensed 08/26-29/2019 remaining within expiry.

Quantity recalledUnknown

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-0585-2020
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: Pain 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 Hydromorphone HCl in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.

Where it was distributed

Nationwide in the U.S.

Nationwide

Questions about this recall

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 08/26/2019 and dispensed 08/26-29/2019 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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

30 other products · FDA event 83996

This product is part of a recall event; the main page for the event is Hydromorphone HCL and Baclofen and Clonidine HCL recalled.

Reported	Class	Recall	Company	Reason	Where
18 Dec 2019	CLASS II	Hydromorphone HCL and Baclofen and Clonidine HCL recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Hydromorphone HCL and Bupivacaine HCL and Baclofen recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Morphine Sulfate and Bupivacaine HCL in all strengths recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Clonidine HCL and Morphine Sulfate in all strengths recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Morphine Sulfate and Bupivacaine HCL and Baclofen recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Baclofen and Morphine Sulfate in all strengths recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Hydromorphone HCL in all strengths, all doses recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Clonidine HCL in all strengths, all doses and all packaging recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Bupivacaine HCL and Clonidine HCL and Hydromorphone HCL recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Glutamine/Arginine/Carnitine in all strengths, all doses recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Baclofen and Clonidine HCL and Morphine Sulfate recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Clonidine HCL PF 750 mcg/mL/Prialt PF recalled by Coast Quality Pharmacy	Coast Quality Pharmacy	Other	Nationwide
18 Dec 2019	CLASS II	Baclofen in all strengths, all doses and all packaging recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Fentanyl Citrate and Clonidine HCL and Morphine Sulfate recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Morphine Sulfate and Bupivacaine HCL and Clonidine HCL recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Clonidine HCL/Hydromorphone HCL in all strengths recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Hydromorphone HCL and Bupivacaine HCL in all strengths recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Morphine Sulfate in all strengths, all doses recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Morphine Sulfate and Fentanyl Citrate and Baclofen recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Hydromorphone HCL and Bupivacaine HCL and Baclofen recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Clonidine HCL and Baclofen in all strengths, all doses recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Hydromorphone HCL and Clonidine HCL in all strengths recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF recalled	Coast Quality Pharmacy	Other	Nationwide
18 Dec 2019	CLASS II	Fentanyl Citrate in all strengths, all doses recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019	CLASS II	Clonidine HCL and Baclofen and Fentanyl Citrate recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide

More recalls from Coast Quality Pharmacy

All 33

Reported	Class	Recall	Company	Reason	Where
3 Jul 2024Drug	CLASS II	Progesterone 200 mg, Compounded, Rx recalled by Coast Quality Pharmacy	Coast Quality Pharmacy	Foreign Material	Nationwide
18 Dec 2019Drug	CLASS II	Clonidine HCL and Baclofen and Fentanyl Citrate recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019Drug	CLASS II	Fentanyl Citrate in all strengths, all doses recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide
18 Dec 2019Drug	CLASS II	Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF recalled	Coast Quality Pharmacy	Other	Nationwide
18 Dec 2019Drug	CLASS II	Hydromorphone HCL and Clonidine HCL in all strengths recalled	Coast Quality Pharmacy	Packaging Defects	Nationwide

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25 Jan 2023Drug	CLASS II	Sensorcaine (Bupivacaine HCl and Epinephrine Injection recalledSensorcaine	Fresenius Kabi USA	Potency & Assay	Nationwide