Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose, Rx Only, (2 mg/mL), ...

FDA Drug Recall #D-0127-2018 — Class III — November 6, 2017

Recall Summary

Recall Number D-0127-2018
Classification Class III — Low risk
Date Initiated November 6, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Claris Lifesciences Inc
Location North Brunswick, NJ
Product Type Drugs

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

Reason for Recall

Superpotent

Distribution Pattern

Nationwide

Lot / Code Information

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

Other Recalls from Claris Lifesciences Inc

Recall # Classification Product Date
D-0614-2017 Class II Fluconazole Injection, USP, 400 mg in 200 mL, R... Mar 10, 2017
D-0615-2017 Class II Levofloxacin Injection in 5% Dextrose, 750 mg i... Mar 10, 2017
D-0613-2017 Class II Ciprofloxacin in Dextrose (5%) Injection, USP, ... Mar 10, 2017
D-0616-2017 Class II Metronidazole Injection, USP, 500 mg/100 mL, Rx... Mar 10, 2017

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.