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Axcentria Pharmaceuticals, LLC

Axcentria Pharmaceuticals, LLC Recalls

All product recalls associated with Axcentria Pharmaceuticals, LLC.

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Recall Summary

Total Recalls

Past Year

Class I (Serious)

Most Recent

May 2014

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–3 of 3 recalls

Hemo-Stat Solution (Axcentria) – Unauthorized Distribution (2014)

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

Class IIModerate

FDAMay 5, 2014Nationwide• Axcentria Pharmaceuticals, LLC

Major Oral Peroxide (Axcentria) – Unstable Expiration (2012)

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.

Class IIILow

FDAAug 17, 2012MI• Axcentria Pharmaceuticals LLC

Infants' Mapap Acetaminophen (Axcentria) – incorrect expiration (2012)

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

Class IIILow

FDAJul 12, 2012MI• Axcentria Pharmaceuticals LLC