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Orphenadrine Recall

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.

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