Recalls / Class III
Class IIID-0822-2016
Product
Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
- Affected lot / code info
- Lot #144332C; Exp. 04/16 Lot #155224; Exp. 05/17
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
- 228 cartons ( 4,560 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-0822-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.