Why it was recalled
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
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
Lot numbers, UPCs & expiration codes
Lot #213655B Exp - 12/31/2017
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-1501-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jul 12, 2014
- FDA report date
- Aug 6, 2014
- Quantity
- 5 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Daiichi Sankyo Pharma Development
Original FDA data
Every field from FDA enforcement report D-1501-2014, 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
- Lot #213655B Exp - 12/31/2017
- Postal code
- 08837-2236
- Report date
- Aug 6, 2014
- Product type
- Drugs
- Recall number
- D-1501-2014
- Classification
- Class II
- Recalling firm
- Daiichi Sankyo Pharma Development
- Product quantity
- 5 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
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 12, 2014
- Initial firm notification
- Telephone
- Center classification date
- Jul 31, 2014