AvKARE Recalls Telmisartan and Amlodipine Tablets Due to Impurities
AvKARE Inc. is recalling Telmisartan and Amlodipine Tablets 80 mg/5 mg due to failed impurities and degradation specifications.
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 agency classified this as an FDA Class III recall, which by definition is unlikely to cause adverse health consequences, fitting the 'Low' severity criteria for documentation or minor specification issues.
Plain-English summary
AvKARE Inc. is recalling Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only (NDC 42291-795-30). The recall involves 397 bottles of the medication.
The recall was initiated because the product failed impurities and degradation specifications, as well as an 18-month long-term stability study. The affected lots are 201916 and 20092, both with an expiration date of 08/2019.
The product was distributed in Arizona and Colorado. Consumers and healthcare providers should stop using the recalled medication and contact their healthcare provider for a replacement or alternative treatment.
The recalled product
- Product
- Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 397
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)
- Lots: 201916 Exp. 08/2019
- 20092 Exp. 08/2019
Distribution
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