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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Claris Lifesciences Inc: Ciprofloxacin in Dextrose Injection Recalled for Superpotency

Agency Publication Date: December 21, 2017
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Summary

Claris Lifesciences Inc. is recalling Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL, a prescription antibiotic used to treat various bacterial infections. This recall was initiated because the product was found to be superpotent, meaning it contains a higher concentration of the active drug than intended. Consumers should be aware that this affects 100 mL flexible bags manufactured for Claris Lifesciences Inc. and distributed nationwide.

Risk

Superpotent medication delivers a higher dose of the drug than prescribed, which can increase the risk of serious side effects or adverse reactions. Patients receiving this superpotent antibiotic may experience toxicity or other complications related to an overdose of ciprofloxacin.

What You Should Do

  1. Check your medical supplies for Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL flexible bags with UPC 336000008242 and NDC 36000-008-249.
  2. Specifically look for the following lot numbers and expiration dates on the packaging: A060192 (Exp 01/2018), A060305 (Exp 02/2018), A061038 (Exp 08/2018), A0A0068 (Exp 12/2018), and A0A0404 (Exp 04/2019).
  3. If you identify an affected product, contact your healthcare provider or pharmacist immediately for guidance on your treatment and to report any potential side effects.
  4. Return any unused or remaining product to the pharmacy or place of purchase for a refund.
  5. Contact the manufacturer, Claris Lifesciences Inc., for further instructions regarding the return of the recalled medication.
  6. For additional information or to report a complaint, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Refund for superpotent drug

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL
Model:
A060192
A060305
A061038
A0A0068
A0A0404
NDC 36000-008-249
UPC Codes:
336000008242
Lot Numbers:
A060192 (Exp 01/2018)
A060305 (Exp 02/2018)
A061038 (Exp 08/2018)
A0A0068 (Exp 12/2018)
A0A0404 (Exp 04/2019)
Date Ranges: January 2018, February 2018, August 2018, December 2018, April 2019

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78446
Status: Resolved
Manufacturer: Claris Lifesciences Inc
Sold By: Hospitals; Pharmacies
Manufactured In: India, United States
Distributed To: Nationwide

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.