KVK-Tech Recalls Oxybutynin Chloride Tablets Due to Wrong Bar Code
KVK-Tech, Inc. is recalling 156 bottles of Oxybutynin Chloride Tablets, 5 mg, because they bear the wrong bar code.
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 involves a minor labeling error (wrong bar code) with no reported illnesses or injuries, fitting the 'Moderate' criteria for minor labeling errors.
Plain-English summary
KVK-Tech, Inc. is recalling 156 bottles of Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only. The product is identified by NDC 10702-201-50, Lot # 15079A, and an expiration date of 10/20.
The recall was initiated because the product bears the wrong bar code. This is a labeling error.
The product was distributed by 10 major distributors throughout the United States. Consumers and healthcare providers should check their inventory for this specific lot and NDC number. If found, the product should be returned to the distributor or the recalling firm.
The recalled product
- Product
- OXYBUTYNIN CHLORIDE (OXYBUTYNIN CHLORIDE)
- Brand
- OXYBUTYNIN CHLORIDE
- Manufacturer
- KVK-Tech, Inc.
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 156
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 #: 15079A
- Exp 10/20
Distribution
Distribution scope not specified by the agency.
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