FDA recall D-0166-2020

AuroMedics Pharma LLC · Class III · drug

Product

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

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status
Ongoing
Initiation date
2019-09-23
Report date
2019-11-06
Voluntary/Mandated
Voluntary: Firm initiated
Location
East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0166-2020