FDA recall D-1467-2019

American Health Packaging · Class II · drug

Product

Anastrozole Tablets, USP, 1 mg, a) 30-count (NDC 68001-155-04) and 1000-count (NDC 68001-155-08) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India For BluePoint Laboratories

Reason for recall

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

Distribution

Nationwide USA

Key facts

Status
Terminated
Initiation date
2019-05-09
Report date
2019-07-17
Termination date
2020-09-09
Voluntary/Mandated
Voluntary: Firm initiated
Location
Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1467-2019