D-1506-2014 Class II Terminated
FDA drug recall D-1506-2014 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).
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
Product Description
Benicar Tablets (olmesartan medoxomil) 40 mg, 30 and 90 count, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-104-30 and 65597-104-90
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
30 count - Lot #0002096 Exp - 12/31/2016; 90 count - Lot #0002058 Exp -12/31/2016