The Recall Desk
LowFDA (Drugs)·D-1032-2018·Announced 2018-08-08

Fluconazole Injection Recalled for Elevated Water Vapor Levels

Renaissance Lakewood, LLC is recalling Fluconazole Injection bags due to elevated water vapor levels. The recall covers 3,664 bags distributed nationwide and in Puerto Rico.

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 by definition is unlikely to cause adverse health consequences, aligning with the 'Low' severity criteria for documentation or minor specification issues.

Plain-English summary

Renaissance Lakewood, LLC is recalling 3,664 bags of Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL). The product is a 100 mL single-dose flexible container bag, prescription only, manufactured for Claris Lifesciences Inc. and by Claris Injectables Ltd. The specific lot number is A0A0156 with an expiration date of 02/19.

The recall was initiated because the lot failed stability specifications, specifically due to elevated water vapor levels. The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences.

The affected product was distributed nationwide and in Puerto Rico. Healthcare providers and patients should stop using the affected lot and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.
Manufacturer
Renaissance Lakewood, LLC
Category
Drug — Antifungal Injection
Hazard
Affected units
3,664

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 #: A0A0156
  • Exp 02/19

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by Renaissance Lakewood, LLC 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 3 products in this recall →

Related recalls

Same manufacturer · Renaissance Lakewood, LLC

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Same hazard · stability failure

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