US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 25, 2016 (10 years ago)

All fluconazole Products

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Lack of Processing Controls

What was recalled

All fluconazole Products, Rx Only, Compounded by RELIABLE DRUG/RELIABLE COMPOUNDING PHARMACY, 801 Irving St., SAN FRANCISCO, CA 94122.

Recalling firm
Reliable Rexall-A Compounding Pharmacy
Origin
CA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1121-2016

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Fluconazole recalls

See all
Class II · Moderate risk Terminated

Fluconazole 200mg Ns 100ml

Reason Lack of sterility assurance

Sentara Infusion Services D-0293-2023
Class III · Low risk Terminated

Fluconazole Injection

Reason Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.

Renaissance Lakewood, LLC D-1033-2018
Class III · Low risk Terminated

Fluconazole Injection

Reason Failed Stability Specifications: lot out of specification for elevated water vapor.

Renaissance Lakewood, LLC NDC 36000-002-10 D-1032-2018
Class III · Low risk Terminated

Fluconazole Injection

Reason Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.

Renaissance Lakewood, LLC NDC 36000-003-06 D-1031-2018
Class II · Moderate risk Terminated

Fluconazole Injection

Reason Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.

Renaissance Lakewood, LLC NDC 36000-002-10 D-0696-2018