Sandoz Orphenadrine Citrate 100 mg Extended Release (ER) Tablets - recalled due to a Nitrosamine Impurity, USA

United States

Sandoz Inc. (“Sandoz”) is initiating a voluntary recall of 13 lots (listed below) of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets to the consumer level. The presence of a nitrosamine (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine (NMOA or Nitroso-Orphenadrine)) impurity, which has the potential to be above the U.S. Food and Drug Administration (FDA)’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, was detected in the lots during recent testing.

These 13 lots of Orphenadrine Citrate ER Tablets were shipped to customers from August 2019 to April 2021. Nitrosamines are substances with carcinogenic potency (substances that could cause cancer) when present above the allowable exposure limits. While the use of product belonging to the recalled lots may represent a risk to patients, to date, Sandoz has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.

Orphenadrine Citrate ER Tablets are used as an adjunct to rest, physical therapy and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions. The product is packaged in 100-count and 1000-count bottles and was distributed nationwide in the USA to wholesalers and distributors.

- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: JX6411. Expiration Date: May 22. Date of Manufacture: 5/24/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: JX6413. Expiration Date: May-22. Date of Manufacture: 5/24/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KC0723. Expiration Date: Aug-22. Date of Manufacture: 8/21/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KC3303. Expiration Date: Aug-22. Date of Manufacture: 8/21/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KE4348. Expiration Date: Nov-22. Date of Manufacture: 11/6/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KE7169. Expiration Date: Nov-22. Date of Manufacture: 11/6/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KE4349. Expiration Date: Nov-22. Date of Manufacture: 11/6/2019
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KL3199. Expiration Date: Mar-23. Date of Manufacture: 3/3/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: KM0072. Expiration Date: Mar-23. Date of Manufacture: 3/3/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0815-022-10. Lot Number: KS3939+. Expiration Date: Mar-23. Date of Manufacture: 3/3/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: LA7704. Expiration Date: Oct-23. Date of Manufacture: 10/6/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: LA7703. Expiration Date: Oct-23. Date of Manufacture: 10/6/2020
- Orphenadrine Citrate ER Tablets. NDC Number: 0185-0022-01. Lot Number: LA9243. Expiration Date: Oct-23. Date of Manufacture: 11/18/2020

This recall of Orphenadrine Citrate ER Tablets is specific to the lots listed above and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product. Any product returned that is not associated with this recall will be destroyed, and no credit will be issued.

Sandoz is notifying its wholesalers and distributors by mail and is arranging for the return of all recalled product. Wholesalers and distributors that have Orphenadrine Citrate ER Tablets subject to this recall should immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.

Consumers who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription.

Company name: Sandoz, Inc.
Brand name: Sandoz
Product recalled: Orphenadrine Citrate 100 mg Extended Release (ER) Tablets
Reason of the recall: Presence of a Nitrosamine Impurity
FDA Recall date: March 22, 2022

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/sandoz-inc-issues-nationwide-recall-13-lots-orphenadrine-citrate-100-mg-extended-release-tablets-due