Reported Apr 5, 2017 · Terminated

Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris…

Claris Lifesciences Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Claris Lifesciences Inc · 1445 US Highway 130 · North Brunswick, NJ · 08902-3100

Is this the product you have?

  • Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only
  • Manufactured forClaris Lifesciences Inc. North Brunswick NJ, 08902
  • ByClaris Injectable Ltd. Gujarat, India, NDC 36000-009-24
Lot codes and dates
    • Lot #: A051288
    • Exp. Sep 2017
Amount recalled
18,360 units (765 cartons x 24 bags)

This recall covers 4 products

The agency filed one notice per product. You are reading one of them; the other 3 are below.

Where it was sold

  • Nationwide

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 18, 2020 · Data as of Sep 19, 6:31 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.