Fenofibrate Tablets Recalled Due to Foreign Valacyclovir Tablet Presence
Hetero Labs is recalling Fenofibrate 145 mg tablets because a foreign Valacyclovir 500 mg tablet was found in the bottles.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard involves a foreign tablet, which is a moderate risk but does not meet the criteria for higher severity classifications without reported injuries.
Plain-English summary
Hetero Labs, Ltd. - Unit III is recalling 5,424 bottles of Fenofibrate Tablets, USP 145 mg. The product is manufactured for Camber Pharmaceuticals, Inc. and is available in 90-count bottles. The specific lot number is E181370 with an expiration date of 5/2020.
The recall was initiated because a foreign object, identified as a Valacyclovir 500 mg tablet, was found co-mingled in a bottle containing the Fenofibrate tablets. This constitutes a presence of a foreign tablet/capsule hazard.
The affected product was distributed in Indiana and Louisiana. Consumers who have this specific lot of Fenofibrate tablets should stop using them and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- FENOFIBRATE (FENOFIBRATE)
- Brand
- FENOFIBRATE
- Manufacturer
- Hetero Labs, Ltd. - Unit III
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 5,424
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 (2)
- Lot #: E181370
- Exp. 5/2020
UPCs (2)
- 0331722596305
- 0331722595308
Distribution
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