Drug product
Clonidine Base Micronized, 55.8 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 12660-0503-01
D-0023-2015
Product summary
- Event
- Event 69243
- Status
- Terminated
- Classification
- Class II
- Quantity
- 55.8 Kg
- Official record key
drug-enforcement:D-0023-2015
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 Numbers: 166247, 166248, Exp 10/2016
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations