Recalls / Class III
Class IIID-0820-2016
Product
Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
- Affected lot / code info
- Lot # 10008624, 10008831; Exp. 10/16 Lot # 10009339; Exp. 02/17 Lot # 10009566,10009627; Exp. 04/17 Lot # 10010200, 20001419A, 20001426A; Exp. 10/17 Lot # 20001732A; Exp. 04/18 Lot # 20001790A, 20001791A, 20001792A; Exp. 05/18
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp. Date
Recalling firm
- Firm
- Impax Laboratories, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 31153 San Antonio Street, N/A, Hayward, California 94544
Distribution
- Quantity
- 28,001 HDPE bottles (14,000,500 capsules)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-17
- FDA classified
- 2016-04-14
- Posted by FDA
- 2016-04-20
- Terminated
- 2016-10-27
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0820-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.