The Recall Desk

Manufacturer

Fresenius Kabi USA LLC (FK USA)

2 recalls in our database name Fresenius Kabi USA LLC (FK USA) as the manufacturing or recalling firm.

What the numbers show

Total
2
Critical
0
Severe
1
Most recent
2013-08-28

Of the 2 recalls from Fresenius Kabi USA LLC (FK USA) we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (50%) 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.

1–2 of 2

  • SevereFDA (Drugs)·D-915-2013·2013-08-28

    Fresenius Kabi Recalls Irinotecan Hydrochloride Injection Due to Crystallization

    Fresenius Kabi USA LLC is recalling 23,672 vials of Irinotecan Hydrochloride Injection because the active ingredient is precipitating in the solution.

    Product
    IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-200-2013·2013-03-20

    Fresenius Kabi Recalls Calcium Glucosate Injection Due to Missing Label

    Fresenius Kabi USA LLC is recalling 155,900 vials of Calcium Glucosate Injection, USP, 10% due to missing labels. The recall is nationwide.

    Product
    CALCIUM GLUCONATE INJECTION, USP, 10% (100 mg/mL), 10 mL, Single Dose Vial, Rx only, For Direct Slow IV or IV Additive Use Only, APP Pharmaceuticals, LLC Schaumburg, IL 60173 --- Product Code 31110, NDC 63323-311-10
    Category
    Drug
    Distribution
    Distributed nationwide