Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.
Reported: August 8, 2018 Initiated: July 11, 2018 #D-1033-2018
Product Description
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.
Reason for Recall
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Details
- Recalling Firm
- Renaissance Lakewood, LLC
- Units Affected
- 12088 bags
- Distribution
- Nationwide and Puerto Rico
- Location
- Lakewood, NJ
Frequently Asked Questions
What product was recalled? ▼
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.. Recalled by Renaissance Lakewood, LLC. Units affected: 12088 bags.
Why was this product recalled? ▼
Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 8, 2018. Severity: Low. Recall number: D-1033-2018.
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