March 2019 FDA Recall Oxybutynin Chloride by Avkare Inc.
D-0990-2019 - Failed Dissolution Specifications
This Class III drug recall was voluntarily initiated by Avkare Inc. on March 1, 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-0990-2019
Failed Dissolution Specifications
03-01-2019
03-20-2019
a) 2947 and b) 3379
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.
AVKARE 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.
Voluntary: Firm initiated
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.
01-14-2020
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, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Batch or Lot Expiration Information
Lot# Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020
