Recalls / Class II
Class IID-0494-2021
Product
Levofloxacin Injection in 5% Dextrose 500 mg in 100 mL 5% Dextrose (5 mg/mL) 24x100 mL Single Dose Flexible Containers NDC 0143-9721-24 West-Ward Pharmaceutical Corp Eatontown, NJ 07724 USA
- Brand name
- Levofloxacin
- Generic name
- Levofloxacin
- Active ingredient
- Levofloxacin
- Route
- Intravenous
- NDCs
- 0143-9720, 0143-9722, 0143-9721
- FDA application
- ANDA091375
- Affected lot / code info
- 2007046.1
Why it was recalled
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Recalling firm
- Firm
- Cardinal Health Inc.
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7000 Cardinal Pl, N/A, Dublin, Ohio 43017-1091
Distribution
- Quantity
- 35 bags
- Distribution pattern
- FL, GA, SC
Timeline
- Recall initiated
- 2021-03-15
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-06-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0494-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.