Renaissance Lakewood Recalls Flucanazole Injection Due to Stability Failures
Renaissance Lakewood, LLC is recalling 1,277 bags of Flucanazole Injection due to superpotent and failed stability specifications.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Renaissance Lakewood, LLC is recalling 1,277 bags of Flucanazole Injection, USP 200 mg in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers. The product is identified by NDC 36000-006-10, Lot A060644, with a May 2018 date. The recall is due to superpotent and failed stability specifications, specifically out-of-specification results for assay and water vapor permeability.
The affected product was distributed nationwide. The recall is classified as Class III by the FDA, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.
Consumers and healthcare providers should stop using the recalled product and contact their supplier or the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
- Manufacturer
- Renaissance Lakewood, LLC
- Category
- Drug — Antifungal Injection
- Affected units
- 1,277
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 A060644
- May 2018
Distribution
Distributed nationwide across the United States.
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