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
Reported: December 27, 2017 Initiated: November 11, 2017 #D-0124-2018
Product Description
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
Details
- Recalling Firm
- Renaissance Lakewood, LLC
- Units Affected
- 24,569 bags
- Distribution
- Nationwide
- Location
- Lakewood, NJ
Frequently Asked Questions
What product 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. Recalled by Renaissance Lakewood, LLC. Units affected: 24,569 bags.
Why was this product recalled? ▼
Superpotent
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 27, 2017. Severity: Low. Recall number: D-0124-2018.
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