Sandoz recalls 100-mg extended-release orphenadrine tablets with nitrosamine impurities above safe limits. Affected lots from 2022-2023 may pose health risks. Consumers should contact Sandoz for details.
CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Sandoz is recalling certain orphenadrine citrate extended-release tablets due to nitrosamine impurities exceeding safe levels. This could pose health risks if taken as directed. The recall affects specific lots manufactured between 2022 and 2023.
Nitrosamine impurities in the tablets exceed the acceptable daily limit. This could lead to health risks if the medication is taken as directed, though the exact risk level is not specified in the recall notice.
Prescription users of the affected lots who take orphenadrine citrate tablets. Those with higher risk may include individuals with certain medical conditions or those taking other medications that interact with orphenadrine.
Check the lot numbers and expiration dates on the packaging: JX6411, JX6413 (exp 05/2022), KC0723, KC3303 (exp 08/2022), KE4348, KE7169, KE4349 (exp 11/2022), KL3199, KM0072, KS3939 (exp 03/2023), LA7704, LA7703, LA9243 (exp 11/2023).
Look for the lot numbers and expiration dates listed in the recall notice to confirm if your tablets are affected.
The recall states that nitrosamine impurities exceed the acceptable daily limit, which could pose health risks if taken as directed. The exact health risks are not specified in the notice.
Check the lot numbers and expiration dates on the packaging: JX6411, JX6413 (exp 05/2022), KC0723, KC3303 (exp 08/2022), KE4348, KE7169, KE4349 (exp 11/2022), KL3199, KM0072, KS3939 (exp 03/2023), LA7704, LA7703, LA9243 (exp 11/2023).
The recall notice does not specify a remedy, so contact Sandoz directly for instructions on what to do with the affected tablets.
We’ve drafted a message you can send Sandoz to request your refund or repair — edit it as you like.
Subject: Recall D-0753-2022 — Sandoz Sandoz Hello, I own a Sandoz that is covered by recall D-0753-2022 from Sandoz. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
