Ascend Amlodipine Besylate Tablets Recalled for Foreign Tablet Presence
Ascend Laboratories is recalling 10 mg Amlodipine Besylate tablets because 2.5 mg tablets were found mixed in the bottles.
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 2/5 (Moderate).
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 III, which indicates the use of, or exposure to, the product is not likely to cause adverse health consequences. The hazard is a minor labeling/packaging error involving a lower dose of the same medication.
Plain-English summary
Ascend Laboratories LLC is recalling 1,212 bottles of Amlodipine Besylate tablets, USP, 10 mg, 1000 count. The product is distributed nationwide in the USA. The specific lot number is 6142626, with an expiration date of 09/19.
The recall was initiated because a 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as 10 mg. This constitutes a presence of foreign tablets/capsules.
Patients and consumers should check their medication for the specific lot number and expiration date listed above. If the product matches the recall details, they should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement.
The recalled product
- Product
- AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
- Brand
- AMLODIPINE BESYLATE
- Manufacturer
- Ascend Laboratories LLC
- Category
- Drug — Prescription Drug
- Affected units
- 1,212
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 #: 6142626
- Exp 09/19
Distribution
Distributed nationwide across the United States.
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Similar recalls
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