Class II · Moderate risk Ongoing
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta Pharma Limited, India, Marketed by: Ajanta…
Reason CGMP Deviations
Is Fenofibrate recalled?
11 FDA recalls mention Fenofibrate. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fenofibrate.
Class II · Moderate risk Ongoing
Fenofibrate Capsules 67 mg, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya…
Reason CGMP Deviations
Class II · Moderate risk Terminated
FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ, 08854…
Reason Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP…
Class III · Low risk Terminated
Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and…
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC…
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC…
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class II · Moderate risk Terminated
Fenoglide (fenofibrate) tablets, 120 mg Tablets, 90 Ct Bottle, Rx Only. Distributed by: Santarus, Inc. San Diego, CA 92130. NDC…
Reason Failed Dissolution Specifications: Failed 24 month dissolution testing.
Class II · Moderate risk Terminated
FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378710077.
Reason Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as one of the following drugs: LUBIPROSTONE, Capsule, 24 MCG…
Class II · Moderate risk Terminated
FENOFIBRATE, Tablet, 54 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00115551110.
Reason Labeling: Label Mixup: FENOFIBRATE, Tablet, 54 mg may have potentially been mislabeled as the following drug: FAMCICLOVIR, Tablet, 500 mg, NDC…
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