AvKARE Recalls Famciclovir Tablets Due to Impurity Levels
AvKARE Inc. is recalling 116 cartons of 500 mg Famciclovir tablets because the product exceeded specifications for unknown impurities.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
AvKARE Inc. is voluntarily recalling 116 cartons of Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons. The specific lot affected is #15152, with an expiration date of 02/2018. The product is prescription-only and was distributed nationwide.
The recall was initiated because the product failed impurities and degradation specifications, specifically testing above the allowed limit for unknown impurities. No specific illnesses or injuries have been reported in the source text.
Consumers and healthcare providers should stop using the affected lot and return the product to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478, NDC 50268-307-13
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Antiviral
- Hazard
- Affected units
- 116
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 #15152
- Exp. 02/2018
Distribution
Distributed nationwide across the United States.
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