Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Amlodipine Besylate and Benazepril HCl Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
What was recalled
Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01
- Recalling firm
- Mylan Pharmaceuticals Inc.
- NDC code
- 0378-6900-01
- Origin
- WV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-66403-010
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.
Other Amlodipine recalls
See all
Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications: low dissolution results
Class II · Moderate risk Terminated
Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Class III · Low risk Terminated
Amlodipine Besylate Tablets
Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
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