Anazao Health Recalls Glutamine, Arginine, and Carnitine Vials Due to Fungal Contamination
Anazao Health is recalling Glutamine/Arginine/Carnitine vials because environmental sampling detected Talaromyces rotundus, a fungus, indicating a lack of processing controls.
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 2/5 (Moderate).
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 voluntary precautionary recall.
Plain-English summary
Coast Quality Pharmacy, LLC dba Anazao Health is recalling Glutamine/Arginine/Carnitine in all strengths, doses, and packaging. The recall affects 17 vials that were filled and dispensed between September 24 and September 26, 2019, and remain within their expiration dates. These products were distributed nationwide in the U.S.
The recall was initiated due to a lack of processing controls. Environmental sampling revealed the presence of 1 CFU (Colony Forming Unit) of Talaromyces rotundus, a type of fungus. This finding indicates a potential contamination issue in the manufacturing or processing environment.
Consumers who have these products should stop using them and contact the recalling firm for further instructions. The FDA has classified this recall as 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
- Glutamine/Arginine/Carnitine in all strengths, all doses and all packaging, AnazaoHealth Corporate 5710 Hoover Blvd Tampa, FL 33634.
- Manufacturer
- Coast Quality Pharmacy, LLC dba Anazao Health
- Category
- Drug — Pharmacy Compounded
- Hazard
- Affected units
- 17
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 and dispensed 09/24-26/2019 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.
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