Drug product
Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg*/40 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc. Parsippany, NJ 07054 NDC 65597-113-30
D-1501-2014
Product summary
- Event
- Event 68793
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5 bottles
- Official record key
drug-enforcement:D-1501-2014
Official wording
Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Code information: Lot #213655B Exp - 12/31/2017
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping