Extended release pain medication recalled for carcinogen content above daily limits
Sandoz is recalling 13 lots of the pain relief drug Orphenadrine Citrate in 100 mg extended release tablets after testing found the carcinogen nitrosamine and the lots might have too much of it.
Here’s what you need to know.
What pain medication is recalled?
Orphenadrine Citrate 100 mg Extended Release tablets that went to customers from August 2019 through April 2021.
The 1,000-count bottle lot is No. KS3939, expiration 03/2023.
The 100-count bottles are in lot Nos. JX6411 and JX6413, expiration 05/2022; KC0723 and KC3303, expiration 08/2022; KE4348, KE 4349 and KE7169, expiration 11/2022; KL3199 and KM0072, expiration 03/2023; LA7704 and LA7703, expiration 10/2023; and LS9243, expiration 11/2023.
Why is it being recalled?
The Sandoz-written recall notice says testing of the lots found a nitrosamine impurity that might be greater than the FDA’s acceptable daily intake. Too much nitrosamine daily over time can increase the risk of the consumer getting cancer.
It’s the second nitrosamine recall of the week.
What should you do if you have these tablets?
First off, relax. Having the recalled tablets doesn’t mean you’re getting cancer tomorrow, next week or next month. But, they are being recalled, so it’s a good idea to stop taking them. Sandoz recommends consulting with your physician on getting another prescription.
Retailers or consumers should reach out to Sandoz about returning the products by emailing sandoz4887@sedgwick.com or calling 844-491-7869, Monday through Friday, 8 a.m. to 5 p.m., Eastern time.
If this or any drug causes a problem, after notifying a medical professional, let the FDA know via its MedWatch Adverse Event page or by filling out a form you can get by calling 800-332-1088.
Only then do you notify the drug company, in this case Sandoz at 800-525-8747, Monday through Friday, 8:30 a.m. to 5 p.m., Eastern time, or by emailing qa.drugsafety@sandoz.com.
This story was originally published March 23, 2022 at 8:27 AM with the headline "Extended release pain medication recalled for carcinogen content above daily limits."
