Axcentria Pharmaceuticals

4 recalls •

💊 Drugs 🏥 Medical Devices

• Categories: Other Drugs, Infusion Pumps, Prescription Drugs

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

💊 Drugs Class I - Dangerous

Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number

May 5, 2014 Other Drugs Nationwide View Details →

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 decay. Calcium Hydroxide Powered is mixed with appropriate vehicle (i.e. Eugenol) prior to administration.

🏥 Medical Devices Class I - Dangerous

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.

Jun 5, 2014 Infusion Pumps View Details →

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

💊 Drugs Class I - Dangerous

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.

Aug 17, 2012 Prescription Drugs View Details →

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,

💊 Drugs Class I - Dangerous

Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014

Jul 12, 2012 Other Drugs View Details →