Recalls / Class II
Class IID-0613-2017
Product
Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
- Affected lot / code info
- Lot #: A051288, Exp. Sep 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
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1445 US Highway 130, North Brunswick, New Jersey 08902-3100
Distribution
- Quantity
- 18,360 units (765 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-0613-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.