Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Product description
Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
Lot numbers, UPCs & expiration codes
Lot #142548; Exp. 05/16 Lot #145036; Exp. 10/16 Lot #151170; Exp. 03/17 Lot #152978; Exp. 09/17 Lot #155080; Exp. 01/18.
Where it was sold
Nationwide
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-0823-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 31, 2016
- FDA report date
- Apr 20, 2016
- Quantity
- 5,034 cartons (151,020 capsules)
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerisource Health Services
Original FDA data
Every field from FDA enforcement report D-0823-2016, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 73715
- Address
- 2550 John Glenn Ave
- Address (line 2)
- Suite A
- Code information
- Lot #142548; Exp. 05/16 Lot #145036; Exp. 10/16 Lot #151170; Exp. 03/17 Lot #152978; Exp. 09/17 Lot #155080; Exp. 01/18.
- Postal code
- 43217-1188
- Report date
- Apr 20, 2016
- Product type
- Drugs
- Recall number
- D-0823-2016
- Classification
- Class III
- Recalling firm
- Amerisource Health Services
- Product quantity
- 5,034 cartons (151,020 capsules)
- Termination date
- Jan 11, 2017
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Fenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
- Distribution pattern
- Nationwide
- Recall initiation date
- Mar 31, 2016
- Initial firm notification
- Letter
- Center classification date
- Apr 14, 2016