Renaissance Lakewood Recalls Superpotent Fluconazole Injection Bags Nationwide

Plain-English summary

Renaissance Lakewood, LLC has voluntarily initiated a recall of 24,569 bags of Fluconazole Injection, USP, 2 mg/mL. The affected products are available in 50 mL and 100 mL sizes and are manufactured for Claris LifeSciences, Inc. by Claris Injectables Ltd. in Gujarat, India. The recall was initiated on November 11, 2017, and the products were distributed nationwide.

The reason for the recall is that the product is superpotent, meaning it contains more active ingredient than the labeled amount. The FDA classified this recall as Class III, which indicates that use of or exposure to the violative product is not likely to cause adverse health consequences. The recall was terminated on April 1, 2020.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed in the recall notice. If you have these products, you should stop using them and contact the recalling firm or your healthcare provider for instructions on how to return or dispose of the medication. This recall is voluntary and was initiated by the firm.

The recalled product

Product

Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India

Manufacturer

Renaissance Lakewood, LLC

Category

Drug — Antifungal

Hazard

• superpotency

Affected units

24,569

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

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