Ascend Recalls Olmesartan Medoxomil Tablets Due to Foreign Tablet Presence
Ascend Laboratories LLC is recalling 34,296 bottles of Olmesartan Medoxomil 20 mg tablets because they may contain a foreign tablet or capsule.
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 FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for minor or theoretical risks.
Plain-English summary
Ascend Laboratories LLC is voluntarily recalling 34,296 bottles of Olmesartan Medoxomil Tablets, USP, 20 mg. The recall is due to the presence of a foreign tablet or capsule in the product. The affected product is distributed nationwide and is identified by Batch No. 20122548 with an expiration date of August 2022.
The product is a prescription-only medication manufactured by Alkem Laboratories Ltd in India and distributed by Ascend Laboratories LLC in Parsippany, NJ. The specific NDC for the recalled 30-tablet bottles is 67877-446-30.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The FDA has classified this recall as Class III, indicating that the use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- OLMESARTAN MEDOXOMIL (OLMESARTAN MEDOXOMIL)
- Brand
- OLMESARTAN MEDOXOMIL
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 34,296
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)
- Batch No. 20122548
- Exp Date: Aug. 2022
UPCs (1)
- 0367877445304
Distribution
Distributed nationwide across the United States.
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