Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and into the drug product.
Fenofibric Acid Tablets, 35 mg, 30-count bottles, labeled as a) FIBRICOR (fenofibric acid) Tablets, NDC 13310-101-07, UPC 3 13310-101-07 8, Manufactured for: AR SCIENTIFIC, INC., Philadelphia, PA 19124 USA; by: MUTUAL PHARMACEUTICAL CO., INC., Philadelphia, PA 19124 USA; b) FIBRICOR (fenofibric acid) Tablets, NDC 49708-101-07, UPC 3 49708 10107 8; c) Fenofibric Acid Tablets, NDC 53489-677-07, UPC 3 53489 67707 3, Rx only, Manufactured by Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512.
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.
Reason Chemical Contamination: The product may contain trace amounts of benzophenone, a component of the label varnish that may leach through the bottle and…
Reason Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the…
Reason Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the…
Reason Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the…
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