Mutual Pharmaceutical Company, Inc. Recall: Fenofibric Acid, immediate release tablet, 105
Mutual Pharmaceutical Company, Inc. Recall: Fenofibric Acid, immediate release tablet, 105 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Mutual Pharmaceutical Company, Inc.; Product: Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count
| Recalling firm | Mutual Pharmaceutical Company, Inc. |
|---|---|
| Product | Fenofibric Acid, immediate release tablet, 105 mg, a) 30 count bottle (NDC 53489-678-07), b) 90 count bottle (NDC 53489-678-90), Rx only, Mutual Pharmaceutical Co., Inc., Philadelphia, PA 19124 USA |
| Reason for recall | Labeling: Incorrect instructions; an error in section 5.11 of the patient insert that results in incorrect medical advice. Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated." The labeling for the recalled lots |
| Classification | Class III (least serious — unlikely to cause adverse health consequences) |
| Status | Terminated |
| Distribution | Nationwide and Puerto Rico. |
| Recall initiated | 20130227 |
| Recall number | D-400-2014 |
| Category | drug |
| State | PA |
| Country | United States |
$29/mo
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