Mutual Pharmaceutical Recalls Fenofibric Acid Tablets Due to Labeling Error
Mutual Pharmaceutical is recalling specific lots of Fenofibric Acid tablets because the patient insert contains incorrect medical advice regarding HDL-C levels.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the use of or exposure to the product is not likely to cause adverse health consequences. The issue is a documentation/labeling error.
Plain-English summary
Mutual Pharmaceutical Company, Inc. is recalling specific lots of Fenofibric Acid, immediate release tablets, 35 mg, 30 count bottles. The recall is due to a labeling error in section 5.11 of the patient insert that results in incorrect medical advice.
The error involves instructions for when a severely depressed HDL-C level is detected. The correct labeling states that fibrate therapy should be withdrawn, the HDL-C level monitored until it returns to baseline, and therapy should not be re-initiated. The recalled lots contain incorrect text in this section.
The affected product is distributed nationwide and in Puerto Rico. The specific lot number is 6561703 with an expiration date of 03/14. Consumers and healthcare providers should check their inventory for this specific lot and NDC number (53489-677-07) and discontinue use if found.
The recalled product
- Product
- Fenofibric Acid, immediate release tablet, 35 mg, 30 count bottle Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA NDC 53489-677-07
- Manufacturer
- Mutual Pharmaceutical Company, Inc.
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 6561703
- exp. 03/14
Distribution
Part of a larger recall action
This product is one of 3 recalled by Mutual Pharmaceutical Company, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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