The Recall Desk
ModerateFDA (Drugs)·D-1033-2018·Announced 2018-08-08

Renaissance Lakewood Recalls Fluconazole Injection Bags for Out-of-Specification Levels

Renaissance Lakewood, LLC is recalling 12,088 bags of Fluconazole Injection because the lots are out of specification for elevated sodium chloride and fluconazole assay levels.

What this means for you

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 FDA classified this as a Class III recall, which is typically a score of 1 or 2. A score of 2 is assigned because the product is a superpotent drug with out-of-specification assay levels, representing a low-risk contamination or labeling error scenario rather than a cosmetic defect.

Plain-English summary

Renaissance Lakewood, LLC is recalling 12,088 bags of Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag. The product is manufactured for Claris Lifesciences Inc. by Claris Injectables Ltd. in Gujarat, India, and is available by prescription only.

The recall was initiated because the affected lots are out of specification for elevated sodium chloride and fluconazole assay levels. The affected lots are A060966, A060967, A060965, and A061023 with an expiration date of 07/18, and lot A060962 with an expiration date of 02/19. The product was distributed nationwide and in Puerto Rico.

Healthcare providers and patients should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be quarantined and not administered until further notice. 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 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 a) 36000-002-10
Manufacturer
Renaissance Lakewood, LLC
Category
Drug — Antifungal Injection
Hazard
Affected units
12,088

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 (7)

  • Lot #: a) A060966
  • A060967
  • A060965
  • A061023
  • Exp 07/18
  • b) A060962
  • 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 →

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Same hazard · out of specification

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