Why it was recalled
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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
Product description
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
Lot numbers, UPCs & expiration codes
lot 6581105 & 6581106 exp. 07/15, and lot 6623001 & 6623002 exp. 01/16
Where it was sold
Nationwide and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-400-2014
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 27, 2013
- FDA report date
- Jan 15, 2014
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
Original FDA data
Every field from FDA enforcement report D-400-2014, exactly as published.
Show all FDA fields
- City
- Philadelphia
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 64727
- Address
- 1100 Orthodox St
- Code information
- lot 6581105 & 6581106 exp. 07/15, and lot 6623001 & 6623002 exp. 01/16
- Postal code
- 19124-3168
- Report date
- Jan 15, 2014
- Product type
- Drugs
- Recall number
- D-400-2014
- Classification
- Class III
- Recalling firm
- Mutual Pharmaceutical Company, Inc.
- Termination date
- Apr 1, 2014
- 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 Specifically, the labeling should read "If a severely depressed HDL-C level is detected, fibrate therapy should be withdrawn, and the HDL-C level monitored until it has returned to baseline, and fibrate therapy should not be re-initiated."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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Feb 27, 2013
- Initial firm notification
- Letter
- Center classification date
- Jan 6, 2014