Impax Laboratories, Inc. recalls Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544,
Labeling: Incorrect or Missing Lot and/or Exp. Date
Recall notice
Labeling: Incorrect or Missing Lot and/or Exp. Date
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Source Page by GovInfoNow · govinfonow.com/recall/43107-impax-laboratories-inc-recalls-fenofibrate-capsules-micronized-134-mg-500 · Recall date March 17, 2016 · FDA enforcement record: FDA #D-0820-2016
Cite this page
“Impax Laboratories, Inc. recalls Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544,.” GovInfoNow, recall dated March 17, 2016. https://govinfonow.com/recall/43107-impax-laboratories-inc-recalls-fenofibrate-capsules-micronized-134-mg-500. Based on FDA recall #D-0820-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0820-2016%22&limit=1).
How to tell if you have this one
- Brand
Impax Laboratories, Inc.- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0820-2016 | Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02; 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 | 28,001 HDPE bottles (14,000,500 capsules) |
| D-0821-2016 | Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02; 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 | 42,239 HDPE bottles ( 21,119,500 capsules) |
Contact Impax Laboratories, Inc.
We’ve drafted a message you can send Impax Laboratories, Inc. to request your refund or repair — edit it as you like.
Subject: Recall D-0820-2016 — Impax Laboratories, Inc. Impax Laboratories, Inc. recalls Fenofibrate Capsules (Micronized) 134 mg, Hello, I own a Impax Laboratories, Inc. recalls Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, that is covered by recall D-0820-2016 from Impax Laboratories, Inc.. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0820-2016 (March 17, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0820-2016 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.