Drug product
Dipyridamole API, NET WT 10 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0084
D-0021-2015
Product summary
- Event
- Event 69243
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 Kg
- Official record key
drug-enforcement:D-0021-2015
Official wording
Reason: 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.
Code information: Lot Number: 161600, Exp 03/2016
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations