Recalls / Class II
Class IID-1501-2014
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
- Affected lot / code info
- Lot #213655B Exp - 12/31/2017
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
- 5 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-1501-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.