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Recall Observatory FDA recall evidence

Drug 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

D-1502-2014

July 12, 2014

Class II

Product summary

Firm
Daiichi Sankyo Pharma Development
Event
Event 68793
Status
Terminated
Classification
Class II
Quantity
262 bottles
Official record key
drug-enforcement:D-1502-2014

Official wording

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

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

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