The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0696-2018·Announced 2018-04-25

Fluconazole Injection Recalled Due to Labeling Mix-Up

Renaissance Lakewood, LLC is recalling Fluconazole Injection due to a labeling mix-up where a 50 mL bag was found in a 100 mL package.

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 2/5 (Moderate).

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 II due to a labeling mix-up. Per the rubric, minor labeling errors and low-risk contamination fall under the Moderate severity category.

Plain-English summary

Renaissance Lakewood, LLC is recalling 1,784 bags of Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL). The recall was initiated after a complaint was received regarding a labeling mix-up, where one bag of the 50 mL volume was found within a package intended for 100 mL bags.

The affected product is identified by Lot # A0A0539 and an expiration date of 05/19. The product was distributed throughout the United States. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

Healthcare providers and consumers should check their inventory for this specific lot number and stop using the product if found. The recalling firm is responsible for managing the recall and ensuring the product is removed from distribution.

The recalled product

Product
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), package in 100 mL bags, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902, By: Claris Injectables Limited, Sarkhei-Bavla Road, Chacharwadi-Vasna, Ahmedabad…
Manufacturer
Renaissance Lakewood, LLC
Category
Drug — Injectable
Hazard
Affected units
1,784

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 #: A0A0539
  • Exp. 05/19

Distribution

Distribution scope not specified by the agency.

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