Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bottle, Rx Only, Manufactured by: Alkem Laboratories…
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited, Goa 103 722, INDIA, NDC 68180-755-01.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Reason Failed Dissolution Specifications: low dissolution results
Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Reason cGMP deviations
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