The Recall Desk

Manufacturer

Renaissance Lakewood, LLC

6 recalls in our database name Renaissance Lakewood, LLC as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
0
Most recent
2018-08-08

Of the 6 recalls from Renaissance Lakewood, LLC we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • ModerateFDA (Drugs)·D-1033-2018·2018-08-08

    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
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1032-2018·2018-08-08

    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
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1031-2018·2018-08-08

    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
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0696-2018·2018-04-25

    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.

    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, I
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-0605-2018·2018-04-04

    Renaissance Lakewood Recalls Flucanazole Injection Due to Stability Failures

    Renaissance Lakewood, LLC is recalling 1,277 bags of Flucanazole Injection due to superpotent and failed stability specifications.

    Product
    Flucanazole Injection, USP 200 mg in in 100 mL (2 mg/mL), 10 Single Dose Flexible Containers, Rx Only, Manufactured for: Claris Lifesciences, Inc. North Brunswick, NJ 08902 By; Claris Injectables Ltd. Gujarat, India --- NDC 36000-006-10
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0124-2018·2017-12-27

    Renaissance Lakewood Recalls Superpotent Fluconazole Injection Bags Nationwide

    Renaissance Lakewood, LLC is voluntarily recalling 24,569 bags of Fluconazole Injection, USP, 2 mg/mL, due to superpotency. The FDA classified this as Class III.

    Product
    Fluconazole Injection, USP, 2 mg/mL, a) 50 mL (NDC 336000-261-10) and b) 100 mL (NDC 33600-002-10), Rx Only, Manufactured for: Claris LifeSciences, Inc. North Brunswick, NJ 08902 By: Claris Injectables Ltd., Gujarat, India
    Category
    Drug
    Distribution
    Distributed nationwide