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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug

Daiichi Sankyo Pharma Development: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping; Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping.

Agency Publication Date: July 31, 2014
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Affected Products

Product: 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 #213655B Exp - 12/31/2017

Lot Numbers:
213655B
Product: 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

30 count - Lot #0002055 Exp - 11/30/2016; 90 count - Lot #0002063 Exp - 12/31/2016

Lot Numbers:
0002055
0002063
Product: Benicar HCT Tablets (olmesartan medoxomil, hydrochlorothiazide) 20 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-105-30

Lot #0002106 Exp - 11/30/2016

Lot Numbers:
0002106
Product: Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg*/25 mg 30 count bottles, Rx Only Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-116-30

Lot #211836 Exp - 11/30/2016

Lot Numbers:
211836
Product: Welchol Tablets (colesevelam HCl) 625 mg, 180 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 ---NDC 65597-701-18

Lot NVWG Exp - 11/30/2016

Lot Numbers:
NVWG
Product: 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

30 count - Lot #0002096 Exp - 12/31/2016; 90 count - Lot #0002058 Exp -12/31/2016

Lot Numbers:
0002096
0002058
Product: Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/12.5 mg, 30 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-106-30

Lot #0002073 Exp - 12/31/2016

Lot Numbers:
0002073
Product: Benicar HCT Tablets (olmesartan medoxomil/hydrochlorothiazide) 40 mg/25 mg, 30 and 90 count bottles, Rx Only, Manufactured for: Daiichi Sankyo, Inc., Parsippany, NJ 07054 --- NDC 65597-107-30 and NDC 65597-107-90

30 count/Lot #0002108 Exp - 12/31/2016; 90 count/Lot #0002078 Exp - 12/31/2016

Lot Numbers:
0002108
0002078

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68793
Status: Resolved
Manufacturer: Daiichi Sankyo Pharma Development
Manufactured In: United States
Units Affected: 5 products (5 bottles; 262 bottles; 108 bottles; 68 bottles; 86 bottles)

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.