Mutual Pharmaceutical Recalls FIBRICOR Tablets Due to Labeling Error
Mutual Pharmaceutical is recalling FIBRICOR (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 FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Mutual Pharmaceutical Company, Inc. is recalling FIBRICOR (fenofibric acid) Tablets, 105 mg, in 30-count and 90-count bottles. The recall involves lots 6504705 and 6504706 with an expiration date of 05/14. The product was distributed nationwide and in Puerto Rico.
The recall was initiated due to a labeling error in section 5.11 of the patient insert. The current text provides incorrect medical advice regarding the management of severely depressed HDL-C levels. The correct instructions state that if a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, the HDL-C level monitored until it returns to baseline, and therapy should not be re-initiated.
Consumers with these specific lots should contact their healthcare provider or pharmacist for guidance. The FDA has classified this as a Class III recall, indicating that the labeling error is unlikely to cause adverse health consequences.
The recalled product
- Product
- FIBRICOR (fenofibric acid) Tablets, 105 mg, a) 30 count bottle (NDC 13310-102-07), b) 90 count bottle (NDC 13310-102-90), Manufactured for AR SCIENTIFIC, INC, Philadelphia, PA 19124 USA
- 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)
- Lots 6504705
- 6504706 exp. 05/14
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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