Recalls / Class III
Class IIID-0127-2018
Product
Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), 100 mL Flexible Bag, Manufactured for: Claris LifeScience Inc. North Brunswick NJ 08902 by Claris Injectables Ltd. Gujarat, India UPC 336000008242 NDC 36000-008-249
- Affected lot / code info
- A060192 01/2018; A060305 02/2018; A061038 08/2018; A0A0068 12/2018; A0A0404 04/2019
Why it was recalled
Superpotent
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
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-11-06
- FDA classified
- 2017-12-21
- Posted by FDA
- 2017-12-27
- Terminated
- 2020-04-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0127-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.