Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Felodipine Extended-Release Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Chemical Contamination; benzophenone leached from the product label varnish
What was recalled
Felodipine Extended-Release Tablets, 10 mg, 100 count bottles, Rx only, Mutual Pharmaceutical Co Inc., Philadelphia, PA --- NDC 53489-370-01
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
- NDC code
- 53489-370-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1422-2015
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.
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Class II · Moderate risk Ongoing
Cleviprex
Reason Lack of Assurance of Sterility
Class III · Low risk Ongoing
Epinephrine Injection
Reason Failed Impurities/Degradations Specifications
Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications: Olmesartan Medoxomil content below specifications
Class II · Moderate risk Ongoing
EPINEPHRINE Injection
Reason Lack of Assurance of Sterility
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