Drug product
Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90
D-1508-2014
Product summary
- Event
- Event 68793
- Status
- Terminated
- Classification
- Class II
- Quantity
- Unavailable
- Official record key
drug-enforcement:D-1508-2014
Official wording
Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Code information: 30 count/Lot #0002108 Exp - 12/31/2016; 90 count/Lot #0002078 Exp - 12/31/2016
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.