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Recall Observatory FDA recall evidence

Drug 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

D-1503-2014

July 12, 2014

Class II

Product summary

Firm
Daiichi Sankyo Pharma Development
Event
Event 68793
Status
Terminated
Classification
Class II
Quantity
108 bottles
Official record key
drug-enforcement:D-1503-2014

Official wording

Reason: Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping

Code information: Lot #0002106 Exp - 11/30/2016

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Temperature Abuse; various products were not stored at Controlled Room Temperature as per USP guidelines during shipping