Recalls / Class III
Class IIID-0124-2018
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
- Affected lot / code info
- 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
Why it was recalled
Superpotent
Recalling firm
- Firm
- Renaissance Lakewood, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1200 Paco Way, Lakewood, New Jersey 08701-5938
Distribution
- Quantity
- 24,569 bags
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-11-11
- FDA classified
- 2017-12-20
- Posted by FDA
- 2017-12-27
- Terminated
- 2020-04-01
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0124-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.