Why it was recalled
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Product description
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
Lot numbers, UPCs & expiration codes
30 count - Lot #0002055 Exp - 11/30/2016; 90 count - Lot #0002063 Exp - 12/31/2016
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1502-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 12, 2014
- FDA report date
- Aug 6, 2014
- Quantity
- 262 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Daiichi Sankyo Pharma Development
Original FDA data
Every field from FDA enforcement report D-1502-2014, exactly as published.
Show all FDA fields
- City
- Edison
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 68793
- Address
- 399 Thornall St
- Code information
- 30 count - Lot #0002055 Exp - 11/30/2016; 90 count - Lot #0002063 Exp - 12/31/2016
- Postal code
- 08837-2236
- Report date
- Aug 6, 2014
- Product type
- Drugs
- Recall number
- D-1502-2014
- Classification
- Class II
- Recalling firm
- Daiichi Sankyo Pharma Development
- Product quantity
- 262 bottles
- Termination date
- Mar 16, 2015
- Reason for recall
- Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 12, 2014
- Initial firm notification
- Telephone
- Center classification date
- Jul 31, 2014