Recalls / Class II
Class IID-1502-2014
Product
Benicar Tablets (olmesartan medoxomil) 20 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-103-30 and NDC 65597-103-90
- Affected lot / code info
- 30 count - Lot #0002055 Exp - 11/30/2016; 90 count - Lot #0002063 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
- Quantity
- 262 bottles
- 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-1502-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.