Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Benicar Tablets
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
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
Affected NDCs
65597-0103-30
65597-0103-90
Compare with the code on your package — it is the most precise check available.
Drug: Olmesartan Category: Blood Pressure Medication
- Recalling firm
- Daiichi Sankyo Pharma Development
- NDC code
- 65597-103-30
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1502-2014 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Olmesartan recalls
See all
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
Failed Dissolution Specifications: low dissolution results
Class II · Moderate risk
Amlodipine and Olmesartan Medoxomil Tablets
cGMP deviations
Class III · Low risk
Olmesartan Medoxomil Tablets
Presence of Foreign Tablet/Capsule
Other recalls by Daiichi Sankyo Pharma Development
All 2014 recalls
Class II · Moderate risk
Benicar HCT Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Benicar HCT Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Benicar Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.
Class II · Moderate risk
Welchol Tablets
Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping
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