AvKARE Recalls Voriconazole Tablets Due to Impurity Specification Failure
AvKARE Inc. is recalling specific lots of Voriconazole Tablets, 200 mg, because they failed impurity specifications for a related compound.
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 FDA classified this as a Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a chemical impurity specification failure without reported illness, fitting the criteria for a moderate severity score.
Plain-English summary
AvKARE Inc. is recalling 1,172 cartons (23,440 tablets) of Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only. The affected product is identified by NDC 50268-804-12 and includes Lot #16933 (Exp 07/2018) and Lot #17054 (Exp 08/2018). The recall was initiated because the product failed impurities/degradation specifications, specifically being out of specification for a related compound C.
The affected units were distributed nationwide. This is a prescription-only medication. The source text does not report any illnesses or injuries associated with this recall.
Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or supplier for disposal or credit in accordance with standard recall procedures.
The recalled product
- Product
- Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 50268-804-12
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Antifungal
- 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 (4)
- Lot #: 16933
- Exp 07/2018
- 17054
- Exp 08/2018
Distribution
Distributed nationwide across the United States.
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