The Recall Desk
ModerateFDA (Drugs)·D-0340-2019·Announced 2018-12-26

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.

What this means for you

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.
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.

Same brand · OXYBUTYNIN CHLORIDE