Sandoz is recalling 13 lots of oral Orphenadrine Citrate 100 mg Extended Release (ER) Tablets due to 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 FDA’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, that 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. This recall of Orphenadrine Citrate ER Tablets is specific to the lots listed on the recall and does not apply to any other strengths of Sandoz Orphenadrine Citrate ER Tablets nor to other lot numbers of the product.
BACKGROUND:
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.
RECOMMENDATIONS:
Patients who have Orphenadrine Citrate ER Tablets being recalled should stop taking the recalled product and immediately consult with their physician to obtain another prescription.Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Sandoz 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.
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