Drug product
Clonidine HCL, 97 Kg, Rx Only, S.I.M.S. , Chemical Product for Medicines Preparation, Made in Italy, NDC 012660-0002
D-0024-2015
Product summary
- Event
- Event 69243
- Status
- Terminated
- Classification
- Class II
- Quantity
- 97 Kg
- Official record key
drug-enforcement:D-0024-2015
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: 167219, 163367, 167220, 167221, Exp 03/2017
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP Deviations