Phytonadione Tablets 5 mg Recalled Due to Failed Impurities Specification
AVKARE Inc. is recalling Phytonadione Tablets 5 mg because the impurity degradant D level failed to meet specification. The affected lot was distributed in Los Angeles, California.
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: This is an FDA Class III recall involving a failed impurities specification with no reported illnesses or injuries. The hazard is a potential quality/purity issue with the pharmaceutical product, making this a moderate, precautionary recall rather than a critical or severe one.
Plain-English summary
AVKARE Inc. is recalling Phytonadione Tablets 5 mg (NDC 50268-661-13) due to a failed impurities specification. During testing, the impurity degradant D level was found to be out of specification.
The recalled product is a prescription-only medication distributed in Los Angeles, California. The affected lot is Lot 38617 with an expiration date of 10/2022. The recall involves 10 cartons of this medication.
Consumers should not use the recalled product. Patients who have taken tablets from this lot should contact their healthcare provider for guidance. Healthcare providers and retailers should quarantine and return the affected product to AVKARE Inc. or the appropriate returns process.
The recalled product
- Product
- Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-661-13
- Manufacturer
- AVKARE Inc.
- Category
- Drug — Pharmaceutical Tablet
- Affected units
- 10
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 (1)
- Lot: 38617 Exp. 10/2022
Distribution
Distributed in 1 state:
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