Reported Apr 20, 2016 · Terminated
Fenofibrate Capsules (Micronized) 134 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) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
- Lot codes and dates
7 of 7 products
Products covered by this recall # Product as published 1 Lot # 10008624, 10008831 2 Exp. 10/16 Lot # 10009339 3 Exp. 02/17 Lot # 10009566,10009627 4 Exp. 04/17 Lot # 10010200, 20001419A, 20001426A 5 Exp. 10/17 Lot # 20001732A 6 Exp. 04/18 Lot # 20001790A, 20001791A, 20001792A 7 Exp. 05/18 - Amount recalled
- 28,001 HDPE bottles (14,000,500 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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