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Class III: unlikely to cause harmTerminated

Claris Lifesciences Ciprofloxacin in Dextrose Recall

Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (…

Claris Lifesciences Inc · North Brunswick, NJ

Risk level
Class III
Reported by FDA
Dec 27, 2017
Recall ID
D-0127-2018
Check your lot numberHow we source this data

Summary

Claris Lifesciences recalled Ciprofloxacin in Dextrose starting Nov 6, 2017. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0127-2018 on Dec 27, 2017. Reason: Superpotent. Status: Terminated.

Why it was recalled

Superpotent

Product description

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

Lot numbers, UPCs & expiration codes

A060192 01/2018; A060305 02/2018; A061038 08/2018; A0A0068 12/2018; A0A0404 04/2019

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0127-2018
Classification
Class III
Status
Terminated
Recall initiated
Nov 6, 2017
FDA report date
Dec 27, 2017
Recall type
Voluntary: Firm initiated
Recalling firm
Claris Lifesciences Inc

Original FDA data

Every field from FDA enforcement report D-0127-2018, exactly as published.

Show all FDA fields
City
North Brunswick
State
NJ
Status
Terminated
Country
United States
Event ID
78446
Address
1445 US Highway 130
Code information
A060192 01/2018; A060305 02/2018; A061038 08/2018; A0A0068 12/2018; A0A0404 04/2019
Postal code
08902-3100
Report date
Dec 27, 2017
Product type
Drugs
Recall number
D-0127-2018
Classification
Class III
Recalling firm
Claris Lifesciences Inc
Termination date
Apr 20, 2020
Reason for recall
Superpotent
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide
Recall initiation date
Nov 6, 2017
Initial firm notification
Letter
Center classification date
Dec 21, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0127-2018, published Dec 27, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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