Axcentria Pharmaceuticals Hemo-Stat Solution, Aluminum chloride 25%, in 37.2 g glass bottles recall — FDA D-1434-2014
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
Overview of recall records associated with Axcentria Pharmaceuticals, LLC, including dates, categories and classifications where available.
Classification mix: Class III: 2, Class II: 1.
Marketed without an Approved NDA/ANDA; product is being manufactured and distributed without a NDC number
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…
Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014
This page summarizes recall records in which the official source identifies Axcentria Pharmaceuticals, LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.