Amerisource Health Services Recalls Fenofibrate Capsules Due to Labeling Errors
Amerisource Health Services is recalling 228 cartons of Fenofibrate Capsules because some units have incorrect or missing lot and expiration dates.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences, and the issue is limited to documentation and labeling errors.
Plain-English summary
Amerisource Health Services is recalling 228 cartons of Fenofibrate Capsules (Micronized), 134 mg, 20-count Unit Dose Blister Packs. The recall was initiated because the product has incorrect or missing lot and/or expiration dates. The affected product is distributed nationwide and includes Lot #144332C (Exp. 04/16) and Lot #155224 (Exp. 05/17).
The product is packaged and distributed by American Health Packaging in Columbus, Ohio. The specific NDC numbers for the affected cartons are 68084-835-32 (Carton of 20) and 68084-835-33 (Individual Dose).
Consumers and healthcare providers should check their inventory for these specific lot numbers and expiration dates. If the product is found, it should be returned to the supplier or the recalling firm for credit. No adverse health consequences are expected from this labeling error.
The recalled product
- Product
- Fenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
- Manufacturer
- Amerisource Health Services
- 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 (3)
- Lot #144332C
- Exp. 04/16 Lot #155224
- Exp. 05/17
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Amerisource Health Services 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.
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