Lupin Recalls Telmisartan and Amlodipine Tablets Due to Stability Failures
Lupin Pharmaceuticals is recalling 12,504 bottles of Telmisartan and Amlodipine tablets because they failed impurity and degradation specifications in a long-term stability study.
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 recall as Class III, which the rubric defines as unlikely to cause adverse health consequences, typically resulting in a score of 1 or 2.
Plain-English summary
Lupin Pharmaceuticals Inc. is recalling 12,504 bottles of Telmisartan and Amlodipine Tablets 80 mg/5 mg. The recall is due to the product failing impurities and degradation specifications during an 18-month long-term stability study. The affected product is a prescription-only medication manufactured by Lupin Limited in Goa, India, for Lupin Pharmaceuticals in Baltimore, Maryland.
The recalled product is identified by NDC 68180-198-06 and includes specific lot codes with expiration dates in April 2019, August 2019, and November 2019. The product was distributed to six wholesalers and drug chains, as well as two mail-order pharmacies, which may have further distributed the medication throughout the United States.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- TELMISARTAN AND AMLODIPINE (TELMISARTAN AND AMLODIPINE)
- Brand
- TELMISARTAN AND AMLODIPINE
- Manufacturer
- Lupin Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 12,504
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 (4)
- G705843 Exp. date April
- 2019 G707763 Exp. date August
- 2019 G800434 Exp. date November
- 2019
UPCs (1)
- 0368180196068
Distribution
Distribution scope not specified by the agency.
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