Aurobindo Recalls Amlodipine and Olmesartan Medoxomil Tablets Due to Discoloration
Aurobindo Pharma USA Inc. is recalling Amlodipine and Olmesartan Medoxomil tablets because they were found to be pink instead of the expected cream color.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic defect (discoloration) with no reported injuries or illnesses.
Plain-English summary
Aurobindo Pharma USA Inc. is recalling Amlodipine and Olmesartan Medoxomil Tablets, 5 mg/40 mg, 30-count bottles. The recall involves 4,464 bottles of the medication, which is distributed nationwide in the U.S.A. The specific lot affected is OWSA18002-A, with an expiration date of 7/2020.
The recall was initiated due to a confirmed pharmacist report that the tablets from this lot were a pink color instead of the expected cream (peach) color. This discoloration is the sole reason for the recall action.
Consumers who have this specific product should check their bottles for the lot number OWSA18002-A and expiration date of 7/2020. If they have the affected product, they should contact their pharmacist or healthcare provider for guidance on how to proceed.
The recalled product
- Product
- AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer
- Aurobindo Pharma USA Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 4,464
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 (2)
- Lot#: OWSA18002-A
- Exp 7/2020
UPCs (4)
- 0365862855305
- 0365862856302
- 0365862854308
- 0365862857309
Distribution
Distributed nationwide across the United States.
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