The Recall Desk

Manufacturer

AuroMedics Pharma LLC

36 recalls in our database name AuroMedics Pharma LLC as the manufacturing or recalling firm.

What the numbers show

Total
36
Critical
4
Severe
19
Most recent
2022-11-02

Of the 36 recalls from AuroMedics Pharma LLC we have scored against our rubric, 4 (11%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 19 (53%) 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.

26–36 of 36

  • SevereFDA (Drugs)·D-0866-2018·2018-05-16

    AuroMedics Recalls Ampicillin and Sulbactam Injection Due to Particulate Matter

    AuroMedics Pharma LLC is recalling 54,720 vials of Ampicillin and Sulbactam for Injection due to confirmed reports of visible red rubber particles.

    Product
    AMPICILLIN AND SULBACTAM — AMPICILLIN AND SULBACTAM (AMPICILLIN SODIUM AND SULBACTAM SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0703-2018·2018-05-09

    AuroMedics Recalls Linezolid Injection Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling Linezolid Injection bags due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.

    Product
    LINEZOLID — LINEZOLID (LINEZOLID)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0704-2018·2018-05-09

    AuroMedics Recalls Levofloxacin IV Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of leaking bags with mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0709-2018·2018-05-09

    AuroMedics Recalls Levofloxacin IV Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling 308,112 bags of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and a confirmed report of mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0707-2018·2018-05-09

    AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling 67,300 bags of Levetiracetam Injection due to a confirmed report of leaking bags and mold found between the outer bag and overwrap.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0705-2018·2018-05-09

    AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling 261,250 bags of Levetiracetam Injection due to a confirmed report of leaking bags and mold found between the outer bag and overwrap.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0708-2018·2018-05-09

    AuroMedics Recalls Levofloxacin Injection Bags Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling specific lots of Levofloxacin in 5% Dextrose Injection due to a lack of assurance of sterility and reports of leaking bags with mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0706-2018·2018-05-09

    AuroMedics Recalls Levetiracetam Injection Due to Sterility Concerns

    AuroMedics Pharma LLC is recalling Levetiracetam Injection due to a lack of assurance of sterility and a confirmed report of leaking bags and mold.

    Product
    LEVETIRACETAM — LEVETIRACETAM (LEVETIRACETAM IN SODIUM CHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0574-2018·2018-03-07

    AuroMedics Recalls Levofloxacin Injection Bags Due to Mold Contamination

    AuroMedics Pharma LLC is recalling 6,072 bags of Levofloxacin in 5% Dextrose Injection because they contain visible particulate matter identified as mold.

    Product
    LEVOFLOXACIN — LEVOFLOXACIN (LEVOFLOXACIN IN 5% DEXTROSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • CriticalFDA (Drugs)·D-0337-2018·2018-02-14

    AuroMedics Recalls Linezolid Injection Bags Due to Mold Contamination

    AuroMedics Pharma LLC is recalling 9,050 bags of Linezolid Injection 600 mg/300 mL because white particulate matter identified as mold was found in one bag.

    Product
    LINEZOLID — LINEZOLID (LINEZOLID)
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0340-2018·2018-02-14

    AuroMedics Recalls Pantoprazole Sodium Injection Due to Glass Particulate

    AuroMedics Pharma LLC is recalling 66,100 vials of Pantoprazole Sodium for Injection because one vial contained a piece of glass.

    Product
    PANTOPRAZOLE SODIUM — PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide