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Axcentria Pharmaceuticals Recalls
4 recalls on record · August 8, 2012 to July 23, 2014 · Drugs, Medical Devices
Recalls by year
12
13
14
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 23, 2014Medical DevicesFDA
Axcentria Pharmaceuticals, LLC recalls Calcium Hydroxide Powder, USP For use in root canal therapy by health care professional. Product Application or Usage
Hazard: One lot of Calcium Hydroxide Powder is being recalled because it was manufactured and distributed without an approved 510k, and the current label does not include instructions for use.
July 23, 2014DrugsFDA
Axcentria Pharmaceuticals, LLC recalls Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles, distributed by Benco Dental, Pittston, PA; Also dist
Hazard: Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
January 30, 2013DrugsFDA
Axcentria Pharmaceuticals LLC recalls Major Oral Peroxide (Carbamide Peroxide 10%), 2 fl oz (60 mL), Distributed by: Major Pharmaceuticals 31778 Enterprise Dr
Hazard: Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.
August 8, 2012DrugsFDA
Axcentria Pharmaceuticals LLC recalls Major brand Infants' Mapap, Acetaminophen Concentrated Drops, 1 FL. OZ. (30 mL.) 80 mg. per 0.8 mL, Cherry Flavor, Distr
Hazard: Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014