Amlodipine and Olmesartan Medoxomil Tablets Recalled for cGMP Deviations
Macleods Pharma USA is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated by the manufacturer.
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 FDA classified this as a Class II recall with no reported illnesses or injuries stated in the source text. The hazard is a manufacturing practice deviation rather than contamination or a direct safety threat, making this a precautionary recall that meets the Moderate severity threshold.
Plain-English summary
Macleods Pharma USA, Inc. is voluntarily recalling 3,672 bottles of Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg in 30-count bottles (NDC 33342-192-07, Lot# BAD62101A, Exp 2/2024) distributed nationwide in the United States.
The recall was initiated due to cGMP deviations identified in the manufacturing process. The FDA classified this as a Class II recall on March 9, 2022, and the manufacturer began notification by letter on February 15, 2022.
Patients currently taking this medication should contact their healthcare provider or pharmacist before stopping use. The product is an oral prescription medication used to treat high blood pressure. The recall status is terminated as of February 17, 2023.
The recalled product
- Product
- AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
- Brand
- AMLODIPINE AND OLMESARTAN MEDOXOMIL
- Manufacturer
- Macleods Pharma Usa Inc
- Hazard
- cgmp-deviation
- manufacturing-defect
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#: BAD62101A
- Exp 2/2024
UPCs (8)
- 0333342192073
- 0333342191076
- 0333342192103
- 0333342190079
- 0333342193100
- 0333342191106
- 0333342193070
- 0333342190109
Distribution
Distributed nationwide across the United States.
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