Drug product
Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30
D-1504-2014
Product summary
- Event
- Event 68793
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1504-2014
Official wording
Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Code information: Lot #211836 Exp - 11/30/2016
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping