Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Olanzapine
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent drug
What was recalled
Olanzapine, Orally Disintegrating Tablets, 5 mg, a) 30-count bottle (NDC 60505-3275-03), b) 100-count blister (NDC 60505-3275-00), Rx only, Manufactured by Apotex Inc. Toronto, Ontario Canada, M9L 1T9
- Recalling firm
- Apotex Inc.
- NDC code
- 60505-3275-03
- Origin
- N/A, Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1079-2015
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.
Other Pine recalls
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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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