The Recall Desk
ModerateFDA (Drugs)·D-0509-2021·Announced 2021-06-02

Cardinal Health Recalls Amlodipine and Olmesartan Medoxomil Tablets Due to Temperature Excursions

Cardinal Health Inc. is recalling 33 bottles of Amlodipine and Olmesartan Medoxomil Tablets due to intermittent temperature excursions during storage.

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 due to CGMP deviations (temperature excursions) without reported illnesses or injuries, fitting the criteria for moderate severity involving low-risk contamination or voluntary precautionary measures.

Plain-English summary

Cardinal Health Inc. is recalling 33 bottles of Amlodipine and Olmesartan Medoxomil Tablets 10 mg/20 mg, 30-count bottles. The recall was initiated due to current good manufacturing practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.

The affected product is identified by lot number BAD62005A and NDC 33342-192-07. The tablets were manufactured for Macleods Pharma USA, Inc. and manufactured by Macleods Pharmaceuticals Ltd. The distribution pattern for this recall includes Florida, Georgia, and South Carolina.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
Brand
AMLODIPINE AND OLMESARTAN MEDOXOMIL
Manufacturer
Cardinal Health Inc.
Category
Drug — Prescription Drug
Hazard
Affected units
33

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)

  • BAD62005A

UPCs (8)

  • 0333342192073
  • 0333342191076
  • 0333342192103
  • 0333342190079
  • 0333342193100
  • 0333342191106
  • 0333342193070
  • 0333342190109

Distribution

Distributed in 3 states:

Part of a larger recall action

This product is one of 198 recalled by Cardinal Health Inc. 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 198 products in this recall →

Related recalls

Same brand · AMLODIPINE AND OLMESARTAN MEDOXOMIL

Same manufacturer · Cardinal Health Inc.

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Same hazard · temperature excursion

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