The Recall Desk
SevereFDA (Drugs)·D-0587-2020·Announced 2019-12-18

Anazao Health Recalls Fentanyl and Morphine Compounded Drugs Due to Fungal Contamination

Anazao Health is recalling compounded fentanyl and morphine drugs after environmental sampling detected Talaromyces rotundus fungi.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard (fungal contamination of injectable drugs) without explicit reports of hospitalization or death falls under the 'Severe' category (Score 4), as it represents a significant risk of harm.

Plain-English summary

Coast Quality Pharmacy, LLC dba Anazao Health is recalling Fentanyl Citrate and Bupivacaine HCl and Morphine Sulfate in all strengths, doses, and packaging. The recall is due to a lack of processing controls, which resulted in environmental sampling revealing 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.

The affected products were filled on August 26, 2019, and dispensed between August 26 and August 29, 2019, provided they remain within their expiry date. The products were distributed nationwide in the U.S.

Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 31 recalled by Coast Quality Pharmacy, LLC dba Anazao Health under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 31 products in this recall →