Multi-event October 2023 FDA Recall Oxybutynin by Zydus Pharmaceuticals
usa Inc
This Multi-event Class II drug recall was voluntarily initiated by Zydus Pharmaceuticals (usa) Inc on October 19, 2023 for the product Oxybutynin. The FDA reported the reason for recall as failed dissolution specifications-out-of-specification (oos) test results observed for dissolution at the 6 month long term time point.. The product was distributed Nationwide and the recall is currently completed.
Reported Recall Events
Recall Number: D-0097-2024
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
10-19-2023
11-15-2023
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) 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.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxybutynin Chloride Extended-Release Tablet USP, 10 mg, 100 count bottles Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-256-01.
Batch or Lot Expiration Information
Lot# M213318, exp. date 11/2024; M213314, exp. date 11/2024; M213315, exp. date 11/2024; M214436, exp. date 11/2024; M214437, exp. date 11/2024; M214438, exp. date 11/2024; M300653, exp. date 12/2024; M300654, exp. date 12/2024
Affected Packages Involved in this Recall
Recall Number: D-0098-2024
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
10-19-2023
11-15-2023
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) 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.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxybutynin Chloride Extended-Release Tablet USP, 15 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-257-01.
Batch or Lot Expiration Information
Lot# M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024
Affected Packages Involved in this Recall
Recall Number: D-0096-2024
Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
10-19-2023
11-15-2023
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Zydus Pharmaceuticals (USA) 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.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Oxybutynin Chloride Extended-Release Tablet USP, 5 mg, 100 count bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd, Baddi, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. NDC # 68382-255-01
Batch or Lot Expiration Information
Lot# M212749, exp. date 11/2024; M214477, exp. date 11/2024; M214478, exp. date 11/2024; M214479, exp. date 11/2024; M214480, exp. date 11/2024
