Drug product
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-192-07.
D-0632-2022
Product summary
- Event
- Event 89600
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,672 bottles
- Official record key
drug-enforcement:D-0632-2022
Official wording
Reason: cGMP deviations
Code information: Lot#: BAD62101A, Exp 2/2024
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
cGMP deviations