The Recall Desk

FDA (Drugs) recall action 80442

Renaissance Lakewood, LLC recalled 3 products on 2018-08-08

The FDA (Drugs) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2018-08-08
Critical
0
Units
18,752

Why these products were recalled

Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.

Failed Stability Specifications: lot out of specification for elevated water vapor.

Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • ModerateFDA (Drugs)··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.

    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
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··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.

    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.
    Category
    Distribution
    1 state
  • LowFDA (Drugs)··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.

    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.
    Category
    Distribution
    1 state