NDC 68382-256

oxybutynin 10 mg tablet, film coated, extended release

On the label: Zydus Pharmaceuticals (USA) Inc..

Where it's made

Recalls

• Oct 19, 2023 · Class II · Zydus Pharmaceuticals (USA) Inc
  Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
  Lots: 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
• Oct 19, 2023 · Class II · Zydus Pharmaceuticals (USA) Inc
  Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
  Lots: 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
• Oct 19, 2023 · Class II · Zydus Pharmaceuticals (USA) Inc
  Failed Dissolution Specifications-out-of-specification (OOS) test results observed for dissolution at the 6 month long term time point.
  Lots: M211541, exp. date 10/2024 M211542, exp. date 10/2024 M212746, exp. date 10/2024 M300660, exp. date 12/2024
• Sep 21, 2023 · Class II · Zydus Pharmaceuticals (USA) Inc
  Failed Dissolution Specifications
  Lots: Lot#: M300652 and M300651, exp. Dec 2024

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug

Oxybutynin: every company that makes it

Form

tablet, film coated, extended release, oral

Strength

10 mg

Approval

ANDA ANDA202332

On the market since

Aug 10, 2017

Package NDCs

68382-256-01 68382-256-05 68382-256-06 68382-256-14 68382-256-16 68382-256-30 68382-256-77

Official label

DailyMed (National Library of Medicine), updated Nov 7, 2023

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