The Recall Desk

Manufacturer

Axcentria Pharmaceuticals, LLC

4 recalls in our database name Axcentria Pharmaceuticals, LLC as the manufacturing or recalling firm.

What the numbers show

Total
4
Critical
0
Severe
0
Most recent
2014-07-23

Of the 4 recalls from Axcentria Pharmaceuticals, 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.

Which agencies issued them

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.

1–4 of 4

  • ModerateFDA (Drugs)·D-1434-2014·2014-07-23

    Axcentria Recalls Hemo-Stat Solution for Lack of FDA Approval

    Axcentria Pharmaceuticals is recalling Hemo-Stat Solution because it was marketed without an approved NDA/ANDA and lacks an NDC number.

    Product
    Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also distributed by Henry Shein, Melville, NY; and Hemoban distributed by iSmile Dental Products, Sacramento, CA
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-2069-2014·2014-07-23

    Axcentria Recalls Calcium Hydroxide Powder Due to Missing 510(k) Approval

    Axcentria Pharmaceuticals is recalling one lot of Calcium Hydroxide Powder because it was distributed without FDA approval and lacks usage instructions.

    Product
    Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage: Provides bactericidal effect on carious dentine. Paste delivered to root apex provides pulp insulation. Protects the vital pulp from infections and further de
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Drugs)·D-134-2013·2013-01-30

    Major Oral Peroxide Recalled Due to Stability Data Concerns

    Axcentria Pharmaceuticals is recalling Major Oral Peroxide because stability data indicates the product degrades below acceptable levels before the printed expiration date.

    Product
    Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Drive, Livonia, MI 48150, NDC 0904-4062-03
    Category
    Drug
    Distribution
    1 state
  • LowFDA (Drugs)·D-1441-2012·2012-08-08

    Axcentria Recalls Infants' Mapap Due to Incorrect Expiration Date Labeling

    Axcentria Pharmaceuticals LLC is recalling 13,128 bottles of Infants' Mapap in Michigan because the outer packaging displays an incorrect expiration date.

    Product
    Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distributed by MAJOR PHARMACEUTICALS, Livonia, MI --- NDC 0904-5255-30,
    Category
    Drug
    Distribution
    1 state