Ranitidine Tablets USP recalled over manufacturing violations

Recall date

September 23, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

AuroMedics Pharma LLC recalls Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN…

Recall number

D-0166-2020

FDA classification

Class III

Brand / firm

AuroMedics Pharma LLC

Sold / distributed

Nationwide within the United States

Why it was recalled

CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles were empty.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp, LLC, 100 Mission Ridge, Goodlettsville, TN 37073 Made in India NDC 55910-092-79