Recalls / Class III
Class IIID-1035-2018
Product
Levofloxacin Injection in 5% Dextrose, 500 mg (5 mg/mL), 500 mg in 100 mL 5% Dextrose, 100 mL Single Use Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-047-24.
- Brand name
- Levofloxacin
- Generic name
- Levofloxacin
- Active ingredient
- Levofloxacin
- Route
- Intravenous
- NDCs
- 36000-045, 36000-046, 36000-047, 36000-048
- FDA application
- ANDA091436
- Affected lot / code info
- Lot#: A0A0954, A0A0958, A0A0970, Exp 09/19
Why it was recalled
Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
Recalling firm
- Firm
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1 Baxter Pkwy, N/A, Deerfield, Illinois 60015-4625
Distribution
- Quantity
- 106,320 bags
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2018-08-01
- FDA classified
- 2018-08-03
- Posted by FDA
- 2018-08-15
- Terminated
- 2020-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1035-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.