Recalls / Class III
Class IIID-1034-2018
Product
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.
- 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 #: A061178, A061183, A061236, Exp 09/18; A0A0937, Exp 08/19; A0A1044, A0A1048, Exp 10/19
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
- 191,256 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-1034-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.