Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.
Reported: August 15, 2018 Initiated: August 1, 2018 #D-1034-2018
Product Description
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.
Reason for Recall
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Details
- Recalling Firm
- Baxter Healthcare Corporation
- Units Affected
- 191,256 bags
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Levofloxacin Injection in 5% Dextrose, 250 mg (5 mg/mL), 250 mg in 50 mL 5% Dextrose, 50 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-046-24.. Recalled by Baxter Healthcare Corporation. Units affected: 191,256 bags.
Why was this product recalled? ▼
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 15, 2018. Severity: Low. Recall number: D-1034-2018.
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