Claris Recalls Ciprofloxacin Injection Due to Superpotency
Claris Lifesciences Inc. is recalling Ciprofloxacin in Dextrose Injection because the product is superpotent. The recall is voluntary and nationwide.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The hazard is superpotency, which is a quality control issue rather than a high-risk pathogen or structural defect.
Plain-English summary
Claris Lifesciences Inc. is voluntarily recalling Ciprofloxacin in Dextrose (5%) Injection, USP 200 mg in 100 mL 5% Dextrose. The product is a prescription-only medication packaged in 100 mL flexible bags. The recall was initiated on November 6, 2017, and is classified as Class III by the FDA.
The reason for the recall is that the product is superpotent, meaning it contains more of the active ingredient than the labeled amount. The recall covers lots with codes A060192, A060305, A061038, A0A0068, and A0A0404. The product was distributed nationwide.
The recall was initiated by the firm and is currently terminated. Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the product if found.
The recalled product
- 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
- Manufacturer
- Claris Lifesciences Inc
- Category
- Drug — Antibiotic Injection
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- A060192 01/2018
- A060305 02/2018
- A061038 08/2018
- A0A0068 12/2018
- A0A0404 04/2019
Distribution
Distributed nationwide across the United States.
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