FDA recall D-1394-2019

American Health Packaging · Class II · drug

Product

Anastrozole Tablets, USP, 1mg, 30-count unit dose blisters per carton, Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC 60687-112-21.

Reason for recall

GMP Deviations: Potential cross contamination due to cleaning procedure failure.

Distribution

Nationwide within the USA

Key facts

Status
Terminated
Initiation date
2019-05-09
Report date
2019-06-26
Termination date
2020-09-30
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1394-2019