On March 21, 2022 Sandoz announced a voluntary recall of 13 lots of its extended pain release medication Orphenadrine Citrate due to the presence of potentially unsafe levels of a nitrosamine. The nitrosamine, NMOA or Nitroso-Orphenadrine, is part of a class of potentially carcinogenic substances that have recently been found in unsafe levels in medications such as Zantac and Valsartan, both of which required major recalls. Various types of cancer have been linked to long term exposure to levels of nitrosamines above the FDA’s Acceptable Daily Intake level of 26.5 ng/day.
The Orphenadrine recall includes 13 lots of Orphenadrine Citrate 100 mg Extended Release (ER) Tablets distributed in US between August 2019 and April 2021. Orphenadrine is prescribed for pain relief to treat common muscle aches and is often recommended in conjunction with rest and physical therapy.
Full information on the recalled lots of Orphenadrine can be found below.
Product Name | NDC Number | Lot Number | Expiration Date | Date of Manufacture |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | JX6411 | 05/2022 | 5/24/2019 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | JX6413 | 05/2022 | 5/24/2019 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | KC0723 | 08/2022 | 8/21/2019 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | KC3303 | 08/2022 | 8/21/2019 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | KE4348 | 11/2022 | 11/6/2019 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | KE7169 | 11/2022 | 11/6/2019 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | KE4349 | 11/2022 | 11/6/2019 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | KL3199 | 03/2023 | 3/3/2020 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | KM0072 | 03/2023 | 3/3/2020 |
Orphenadrine Citrate ER Tablets | 0815-022-10 | KS3939+ | 03/2023 | 3/3/2020 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | LA7704 | 10/2023 | 10/6/2020 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | LA7703 | 10/2023 | 10/6/2020 |
Orphenadrine Citrate ER Tablets | 0185-0022-01 | LA9243 | 11/2023 | 11/18/2020 |
GoldenbergLaw has over 35 years of experience litigating defective pharmaceutical cases. Our Minnesota-based Orphenadrine attorneys have helped thousands of individuals who have suffered harm due to a recalled product recover the compensation they deserve from negligent manufacturers. If you or a loved one has taken Orphenadrine and received a recall letter or been diagnosed with cancer, contact our attorneys today for a free Orphenadrine lawsuit consultation.
