Class II · Moderate risk Ongoing
Fenofibrate Capsules
Reason CGMP Deviations
Fenofibrate Capsules
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp. Date
What was recalled
Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
- Recalling firm
- Impax Laboratories, Inc.
- NDC code
- 0115-0522-02
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0820-2016
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 Fenofibrate recalls
See all
Class II · Moderate risk Ongoing
Fenofibrate Capsules 67 mg
Reason CGMP Deviations
Class II · Moderate risk Terminated
Fenofibrate Capsules
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Fenofibrate Tablets
Reason Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
Class III · Low risk Terminated
Fenofibrate Capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
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