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
Reported: April 4, 2018 Initiated: March 2, 2018 #D-0605-2018
Product Description
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
Details
- Recalling Firm
- Renaissance Lakewood, LLC
- Units Affected
- 1277 bags
- Distribution
- Nationwide
- Location
- Lakewood, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Renaissance Lakewood, LLC. Units affected: 1277 bags.
Why was this product recalled? ▼
Superpotent and Failed Stability Specifications; out of specification results for assay and water vapor permeability
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 4, 2018. Severity: Low. Recall number: D-0605-2018.
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