FDA recall D-0021-2015

Product

Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084

Reason for recall

cGMP Deviations: GYMA laboratories Inc. has recalled multiple Active Pharmaceutical Ingredients manufactured in Italy upon receipt of a Rapid Alert Notification issued by The Italian Medicines Agency due to lack of good manufacturing practices.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2014-07-09

Report date

2014-10-22

Termination date

2018-06-04

Voluntary/Mandated

Voluntary: Firm initiated

Location

Westbury, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0021-2015