Class II · Moderate risk
Fenofibrate Capsules
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
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
Affected NDC
0115-0533-02
Compare with the code on your package — it is the most precise check available.
Drug: Fenofibrate Category: Cholesterol Medication
- Recalling firm
- Impax Laboratories, Inc.
- NDC code
- 0115-0533-02
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0821-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Fenofibrate recalls
See all
Class II · Moderate risk
Fenofibrate Capsules 67 mg
CGMP Deviations
Class II · Moderate risk
Fenofibrate Capsules
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk
Fenofibrate Tablets
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
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp Date
Other recalls by Impax Laboratories, Inc.
All 2016 recalls
Class I · High risk
Lamotrigine Orally Disintegrating Tablets
Labeling; Label Mixup; box labeled to contain 200 mg blister packs but actually contain 100 mg blister packs
Class III · Low risk
Fenofibrate Capsules
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class II · Moderate risk
Dextroamphetamine Sulfate Tablets USP
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Dextroamphetamine Sulfate Tablets USP
Failed Impurities/Degradation Specifications
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