Recalls / Class II
Class IID-0615-2017
Product
Levofloxacin Injection in 5% Dextrose, 750 mg in 150 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-048-24
- 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 #: A060040, Exp. Dec 2017
Why it was recalled
Lack of Assurance of Sterility: there is potential of a leak from the primary container which may result in a potential breach of sterility and contamination of the product.
Recalling firm
- Firm
- Claris Lifesciences Inc
- Manufacturer
- Baxter Healthcare Corporation
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1445 US Highway 130, North Brunswick, New Jersey 08902-3100
Distribution
- Quantity
- 24,456 units (1019 cartons x 24 bags)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-03-10
- FDA classified
- 2017-03-24
- Posted by FDA
- 2017-04-05
- Terminated
- 2020-09-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0615-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.