Claris Ciprofloxacin Injection Recalled for Potential Sterility Breach
Claris Lifesciences Inc. is recalling Ciprofloxacin in Dextrose Injection due to a potential leak that may compromise sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential breach of sterility in an injectable drug, which carries a significant risk of serious injury or hospitalization if contaminated.
Plain-English summary
Claris Lifesciences Inc. is recalling 18,360 units of Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose. The product is identified by Lot # A051288 and has an expiration date of September 2017. The recall was initiated because of a lack of assurance of sterility.
The recall is due to a potential leak from the primary container, which may result in a breach of sterility and contamination of the product. The affected units were distributed nationwide.
Healthcare providers and patients should discontinue use of the affected product and contact Claris Lifesciences Inc. for further instructions.
The recalled product
- Product
- Ciprofloxacin in Dextrose (5%) Injection, USP, 400 mg in 200 mL 5% Dextrose, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-009-24
- Manufacturer
- Claris Lifesciences Inc
- Category
- Drug — Antibiotic Injection
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 (2)
- Lot #: A051288
- Exp. Sep 2017
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Claris Lifesciences Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
Same manufacturer · Claris Lifesciences Inc
See all →- ModerateClaris Recalls Ciprofloxacin Injection Due to Superpotency
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Similar recalls
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FDA (Drugs) · 2017-12-27
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