February 2019 FDA Recall Oxybutynin Chloride by Lannett Company Inc.
D-0996-2019 - Failed Dissolution Specifications
This Class III drug recall was initiated by Lannett Company Inc. on February 21, 2019 for the product Oxybutynin Chloride. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-0996-2019
Failed Dissolution Specifications
02-21-2019
03-20-2019
14,448 bottles
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Lannett Company Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
N/A
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide, including Puerto Rico.
11-06-2020
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37
Batch or Lot Expiration Information
Lot# Lots: 18226783A, exp 07/2021 and 18232540A, exp 08/2021
