FDAFDA · Food and drugs·Recall number D-0021-2015
Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084
Published October 22, 2014 · Recall initiated: July 9, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Gyma Laboratories Of Amer,Inc
- Distributor
- Nationwide
- Lot
- Lot Number: 161600, Exp 03/2016
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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