Renaissance Lakewood, LLC recalls Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactur…
- Recall date
- November 11, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0124-2018
- FDA classification
- Class III
- Brand / firm
- Renaissance Lakewood, LLC
- Sold / distributed
- Nationwide
Why it was recalled
Superpotent
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
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
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