Recalls / Class III
Class IIID-0823-2016
Product
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.
- Affected lot / code info
- 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.
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date
Recalling firm
- Firm
- Amerisource Health Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave, Suite A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 5,034 cartons (151,020 capsules)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-31
- FDA classified
- 2016-04-14
- Posted by FDA
- 2016-04-20
- Terminated
- 2017-01-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0823-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.