Anazao Health Recalls Hydromorphone, Baclofen, and Clonidine Combination Drugs
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Hydromorphone HCL, Baclofen, and Clonidine HCL combination drugs due to fungal contamination found during environmental sampling.
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. According to the severity rubric, FDA Class II recalls with potential for adverse health consequences (such as fungal contamination in a drug) are categorized as Severe (Score 4), particularly when the agency classification is explicitly Class II and the hazard involves biological contamination.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is voluntarily recalling all strengths, doses, and packaging of Hydromorphone HCL and Baclofen and Clonidine HCL. The recall is being conducted because environmental sampling revealed the presence of Talaromyces rotundus, a fungus, indicating a lack of processing controls.
The affected products were filled and dispensed between August 26 and 29, 2019, and September 27 and October 3, 2019. These products were distributed nationwide in the United States. The recall includes all lots remaining within their expiration dates.
Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement. This recall is classified as FDA Class II, meaning there is a reasonable probability that the use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Hydromorphone HCL and Baclofen and Clonidine HCL 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
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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