Claris Fluconazole Injection Recalled for Potential Sterility Breach
Claris Lifesciences is recalling Fluconazole Injection due to a potential leak that could compromise sterility and contaminate the product.
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, which corresponds to a Severe severity score under the rubric, particularly given the risk of contamination in an injectable medication.
Plain-English summary
Claris Lifesciences Inc. is recalling Fluconazole Injection, USP, 400 mg in 200 mL (NDC 36000-003-06). The recall involves 18,096 units, consisting of 3,016 cartons containing 6 bags each. The affected product is identified by Lot # A051052 and has an expiration date of August 2017.
The recall was initiated due to a lack of assurance of sterility. The FDA notes that there is a potential for a leak from the primary container, which may result in a breach of sterility and contamination of the product. The distribution of the affected units was nationwide.
Healthcare providers and patients should stop using the affected lots of Fluconazole Injection. Consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recalled description, it should be returned to the pharmacy or healthcare provider for disposal or replacement.
The recalled product
- Product
- Fluconazole Injection, USP, 400 mg in 200 mL, Rx only, Manufactured for: Claris Lifesciences Inc. North Brunswick NJ, 08902, By: Claris Injectable Ltd. Gujarat, India, NDC 36000-003-06
- Manufacturer
- Claris Lifesciences Inc
- Category
- Drug — Antifungal 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 #: A051052
- Exp. Aug 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
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