Recalls / Class II
Class IID-1508-2014
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
- Affected lot / code info
- 30 count/Lot #0002108 Exp - 12/31/2016; 90 count/Lot #0002078 Exp - 12/31/2016
Why it was recalled
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Recalling firm
- Firm
- Daiichi Sankyo Pharma Development
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 399 Thornall St, Edison, New Jersey 08837-2236
Distribution
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-07-12
- FDA classified
- 2014-07-31
- Posted by FDA
- 2014-08-06
- Terminated
- 2015-03-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1508-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.