FDAJuly 11, 2018drug
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
Official recall recorded by the U.S. Food & Drug Administration.
The hazard
Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.
What to do
FDA enforcement status: Terminated
Brands named
renaissance lakewoodrenaissance
Recall history
Other federal recalls tied to the same brand — a factual pattern, straight from the source data.
- FDASmall Fruit Tray NET WT 1 LB 10 OZ (26 OZ) 737 g UPC 8 26766 19098 02023-11-24
- FDALarge Fruit Tray with Dip NET WT 73.5 OZ (4 LBS (.5 OZ) 2.08 kg UPC 8 26766 19101 7 Dist. By: Renaissance Food Group LLC Rancho Cordova, CA 956702023-11-24
- FDACantaloupe Chunks 9oz (255g) UPC 8 26766 13923 1 & 18 oz (1 LB 2 OZ) 5??g UPC 8 26766 13917 0 Dist By Renaissance Food Group, LLC 4322 Moreland Avenue, Conley, GA 302882023-11-24
- FDAFruit Medley NET WT 9 OZ (255 g) UPC 8 26766 13927 9 & 18 OZ (1 LB 2 OZ) 510 g UPC 8 26766 13921 7 Dist. By: Renaissance Food Group LLC 4322 Moreland Ave Conley, GA 302882023-11-24
- FDAMixed Fruit Bowl NET WT 32 oz (2 lbs) 907 g UPC 8 26766 13944 6 Dist. By: Renaissance Food Group, LLC 4322 Moreland Ave Conley, GA 302882023-11-24
- FDASprouts Farmers Fruit Tray NET WT 32 OZ (2 LB) 907g UPC 8 26766 89481 92023-11-24
- FDATrader Joe's Fresh Cut Fruit Cantaloupe Chunks NET WT 16 OZ (1 LB) 453g UPC 0095 2668, DIST & SOLD EXCLUSIVELY BY TRADER JOE'S MONROVIA, CA 910162023-11-24
- FDASprouts Tropical Fruit Blend NET WT 10 OZ (283g) UPC 8 26766 89490 1 Manutfactured Exclusively for Sprouts Farmers Market Phoenix, Arizona 905042023-11-24
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