Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.
Reported: October 3, 2018 Initiated: September 25, 2018 #D-1215-2018
Product Description
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.
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
- 523,896 bags
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Deerfield, IL
Frequently Asked Questions
What product was recalled? ▼
Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c) 150 mL (NDC 36000-048-24) Container bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India.. Recalled by Baxter Healthcare Corporation. Units affected: 523,896 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 October 3, 2018. Severity: Low. Recall number: D-1215-2018.
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