Sandoz is voluntarily recalling 13 lots of Orphenadrine Citrate 100mg extended-release (ER) tablets to the consumer level due to the presence of a nitrosamine impurity, NMOA or nitroso-orphenadrine, above the Food and Drug Administration’s (FDA) acceptable daily intake limit.

Orphenadrine citrate ER tablet is indicated as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.

The recalled lots of Orphenadrine Citrate 100mg ER Tablets were distributed nationwide in the United States from August 2019 to April 2021 and are supplied in 100-count and 1000-count bottles. There is 1 affected lot for the 1000-count bottle: NDC Number 0185-022-10; Lot Number KS3939; Expiration Date 03/2023; Date of Manufacture 3/3/2020.

The following is a list of the affected lots for the 100-count bottle, NDC Number 0185-0022-01:

  • Lot Number JX6411; Expiration Date 05/2022; Date of Manufacture 5/24/2019;
  • Lot Number JX6413; Expiration Date 05/2022; Date of Manufacture 5/24/2019;
  • Lot Number KC0723; Expiration Date 08/2022; Date of Manufacture 8/21/2019;
  • Lot Number KC3303; Expiration Date 08/2022; Date of Manufacture 8/21/2019;
  • Lot Number KE4348; Expiration Date 11/2022; Date of Manufacture 11/6/2019;
  • Lot Number KE7169; Expiration Date 11/2022; Date of Manufacture 11/6/2019;
  • Lot Number KE4349; Expiration Date 11/2022; Date of Manufacture 11/6/2019;
  • Lot Number KL3199; Expiration Date 03/2023; Date of Manufacture 3/3/2020;
  • Lot Number KM0072; Expiration Date 03/2023; Date of Manufacture 3/3/2020;
  • Lot Number LA7704; Expiration Date 10/2023; Date of Manufacture 10/6/2020;
  • Lot Number LA7703; Expiration Date 10/2023; Date of Manufacture 10/6/2020;
  • Lot Number LA9243; Expiration Date 11/2023; Date of Manufacture 11/18/2020.

To date, Sandoz has not received any reports of adverse events related to this recall. 

Adverse events or quality issues should be reported to the FDA’s MedWatch Adverse Event Reporting program

Reference

Sandoz, Inc. issues nationwide recall of 13 lots of Orphenadrine Citrate 100 mg Extended Release Tablets due to presence of a nitrosamine impurity. News release. Sandoz, Inc. Accessed March 23, 2022. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due