The Recall Desk
ModerateFDA (Drugs)·D-1501-2014·Announced 2014-08-06

Daiichi Sankyo Recalls Azor Tablets Due to Temperature Abuse During Shipping

Daiichi Sankyo is recalling 5 bottles of Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg/40 mg 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 temperature abuse during shipping which may affect product stability. There are no reports of serious injury or death, and the risk is considered moderate as it relates to potential loss of efficacy rather than immediate acute harm.

Plain-English summary

Daiichi Sankyo Pharma Development is recalling 5 bottles of Azor Tablets (amlodipine and olmesartan medoxomil) 10 mg/40 mg, 30-count bottles. The product is prescription-only and was manufactured for Daiichi Sankyo, Inc. in Parsippany, NJ. The specific lot number is 213655B, with an expiration date of 12/31/2017.

The recall was initiated because the products were not stored at Controlled Room Temperature as per USP guidelines during shipping. This temperature abuse may affect the stability or efficacy of the medication. The recall is classified as Class II by the FDA, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The affected product was distributed nationwide. Patients who have this specific lot of Azor Tablets should contact their healthcare provider or pharmacist for guidance on whether to stop taking the medication and how to obtain a replacement.

The recalled product

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
Manufacturer
Daiichi Sankyo Pharma Development
Category
Drug — Prescription Medication
Hazard
Affected units
5

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 #213655B Exp - 12/31/2017

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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