Anazao Health Recalls Clonidine and Morphine Sulfate Due to Fungal Contamination
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL and Morphine Sulfate products due to the presence of Talaromyces rotundus fungi.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential health risks.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Clonidine HCL and Morphine Sulfate in all strengths, doses, and packaging. The recall is being conducted because environmental sampling revealed the presence of Talaromyces rotundus, a type of fungi, indicating a lack of processing controls.
The affected products were filled and dispensed between August 26 and August 29, 2019, and between September 27 and October 3, 2019. The recall covers all lots remaining within their expiration dates. Distribution was nationwide in the U.S.
Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for instructions on disposal or replacement.
The recalled product
- Product
- Clonidine HCL and Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth 5710 Hoover Blvd Tampa, FL 33634.
- Manufacturer
- Coast Quality Pharmacy, LLC dba Anazao Health
- Category
- Drug — Pharmacy Compounded
- Hazard
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.
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