Class II · Moderate risk Ongoing
Amlodipine and Olmesartan Medoxomil Tablets
Reason Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications
Loxapine Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
What was recalled
Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A. NDC 51079-903-20.
- Recalling firm
- Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- NDC code
- 51079-903-20
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0823-2018
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
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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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