Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India

FDA recall notice · announced December 27, 2017 · Renaissance Lakewood

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

The product

Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India

Reason for recall

Superpotent

Notes

Distribution: Nationwide
Lot/code information: a) A060174 01/13/2018, A060257 02/28/2018, A060692 05/31/2018, A061165 09/30/2018, A0A0143 01/31/2019, A0A0347 03/31/2019, and A0A0424 04/30/2019 ; b) A060027 12/31/2017
Quantity: 24,569 bags
Status: Terminated
Products in this recall event:
- Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectable (D-0124-2018)

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