Reported Apr 20, 2016 · Terminated
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544,…
Impax Laboratories, Inc.
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Impax Laboratories, Inc. · 31153 San Antonio Street · Hayward, CA · 94544
Is this the product you have?
- Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 Lot # 10008320 2 Exp. 05/16 Lot # 10008744, 10008974 3 Exp. 11/16 Lot # 10009342 4 Exp. 03/17 Lot # 10010202 5 Exp. 09/17 Lot # 20001416A 6 Exp. 10/17 Lot # 20001557A 7 Exp. 01/18 Lot # 20001675A 8 Exp. 03/18 Lot # 20001831A 9 Exp. 06/18 - Amount recalled
- 42,239 HDPE bottles ( 21,119,500 capsules)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp. Date
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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