Reliable Drug Recalls Fluconazole Products Due to Processing Control Issues
Reliable Drug is recalling all fluconazole products compounded between March 2015 and March 2016 due to 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
Reliable Drug/Reliable Compounding Pharmacy is recalling all fluconazole products, which are prescription-only medications. The recall covers all lots compounded between March 24, 2015, and March 24, 2016, that are within their expiration dates.
The recall was initiated due to a lack of processing controls. The affected products were distributed in the United States, specifically in California, Hawaii, and New Mexico.
Consumers who have these fluconazole products should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.
- Manufacturer
- Reliable Rexall-A Compounding Pharmacy
- Category
- Drug — Antifungal
- Hazard
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 compounded between 03/24/2015 and 03/24/2016 and within expiry.
Distribution
Part of a larger recall action
This product is one of 70 recalled by Reliable Rexall-A Compounding Pharmacy 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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