The Recall Desk
ModerateFDA (Drugs)·D-1504-2014·Announced 2014-08-06

Daiichi Sankyo Recalls Tribenzor Tablets Due to Temperature Abuse

Daiichi Sankyo is recalling specific lots of Tribenzor tablets because they were not stored at controlled room temperature during shipping.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves storage conditions that may affect product quality without reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

Daiichi Sankyo Pharma Development is recalling Tribenzor Tablets (olmesartan medoxomil/amlodipine/hydrochlorothiazide), 40 mg/5 mg/25 mg, 30 count bottles. The recall affects Lot #211836 with an expiration date of 11/30/2016. The product was distributed nationwide.

The recall was initiated because various products were not stored at Controlled Room Temperature as per USP guidelines during shipping. This temperature abuse may affect the stability and efficacy of the medication.

Consumers and healthcare providers should stop using the affected lot and return the product to the pharmacy or contact Daiichi Sankyo for further instructions.

The recalled product

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
Manufacturer
Daiichi Sankyo Pharma Development
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • Lot #211836 Exp - 11/30/2016

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Daiichi Sankyo Pharma Development under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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