The Recall Desk
ModerateFDA (Drugs)·D-0593-2020·Announced 2019-12-18

Morphine Sulfate and Bupivacaine HCL Recalled Due to Fungal Contamination

Coast Quality Pharmacy is recalling Morphine Sulfate and Bupivacaine HCL because environmental sampling detected Talaromyces rotundus, a fungus.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score.

Plain-English summary

Coast Quality Pharmacy, LLC dba Anazao Health is recalling Morphine Sulfate and Bupivacaine HCL in all strengths, doses, and packaging. The recall was initiated because environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi, indicating a lack of processing controls.

The affected products were filled on August 26, 2019, and dispensed between August 26 and August 29, 2019, provided they remain within their expiration date. The recall is classified as Class II by the FDA.

Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Morphine Sulfate and Bupivacaine HCL 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 →