D-1501-2014 Class II Terminated
FDA drug recall D-1501-2014 was initiated by Daiichi Sankyo Pharma Development on July 12, 2014 and is designated Class II. Reason for recall: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping The recall status is terminated (terminated March 16, 2015). Affected quantity: 5 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 6, 2014
- Initiation Date
- July 12, 2014
- Termination Date
- March 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5 bottles
Product Description
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
Reason for Recall
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Distribution Pattern
Nationwide
Code Information
Lot #213655B Exp - 12/31/2017