Impax Recalls Fenofibrate Capsules Due to Incorrect or Missing Labeling
Impax Laboratories is recalling 28,001 bottles of Fenofibrate Capsules (Micronized) 134 mg because the bottles have incorrect or missing lot and expiration dates.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this recall as Class III, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation and labeling defect rather than a physical hazard.
Plain-English summary
Impax Laboratories, Inc. is recalling 28,001 HDPE bottles of Fenofibrate Capsules (Micronized) 134 mg, 500-count, Rx Only. The product is distributed by Impax Generics in Hayward, CA, and carries the NDC 0115-0522-02. The recall covers a total of 14,000,500 capsules.
The recall was initiated because the product has incorrect or missing lot and/or expiration dates. The affected lots include # 10008624, 10008831, 10009339, 10009566, 10009627, 10010200, 20001419A, 20001426A, 20001732A, 20001790A, 20001791A, and 20001792A, with expiration dates ranging from 10/16 to 05/18. The product was distributed nationwide.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or healthcare provider for a replacement or refund. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
The recalled product
- Product
- Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
- Manufacturer
- Impax Laboratories, Inc.
- Category
- Drug — Prescription Medication
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (13)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Impax Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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