Recalls / Class III
Class IIID-0821-2016
Product
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
- Affected lot / code info
- Lot # 10008320; Exp. 05/16 Lot # 10008744, 10008974; Exp. 11/16 Lot # 10009342; Exp. 03/17 Lot # 10010202; Exp. 09/17 Lot # 20001416A; Exp. 10/17 Lot # 20001557A; Exp. 01/18 Lot # 20001675A; Exp. 03/18 Lot # 20001831A; Exp. 06/18
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
- 42,239 HDPE bottles ( 21,119,500 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-0821-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.