The Recall Desk
Agency classClass IIIOur severity:LowFDA (Drugs)·D-1031-2018·Announced 2018-08-08

Renaissance Lakewood Recalls Fluconazole Injection Bags Due to Stability Failures

Renaissance Lakewood, LLC is recalling 3,000 bags of Fluconazole Injection due to elevated sodium chloride and water vapor levels.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

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 1/5 (Low).

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 voluntarily recalling 3,000 bags of Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag. The product is identified by Lot # A061213 with an expiration date of 09/18. The bags were distributed nationwide and in Puerto Rico.

The recall was initiated because the lot failed stability specifications, specifically showing elevated levels of sodium chloride and water vapor. 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.

Healthcare providers and patients should discontinue use of the affected product and contact Renaissance Lakewood, LLC for further instructions or to arrange for a return.

The recalled product

Product
Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.
Manufacturer
Renaissance Lakewood, LLC
Category
Drug — Injectable
Hazard
Affected units
3,000

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 # A061213
  • Exp 09/18

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 →

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