Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10

FDA recall notice · announced April 4, 2018 · Renaissance Lakewood

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The product

Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10

Reason for recall

Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability

Notes

Distribution: Nationwide
Lot/code information: Lot A060644, May 2018
Quantity: 1277 bags
Status: Terminated
Products in this recall event:
- Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. (D-0605-2018)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.