Recent tests of 13 lots of the skeletal muscle relaxant Orphenadrine Citrate 100 mg Extended Release (ER) found unacceptably high levels of a nitrosamine impurity in the tablets, leading manufacturer Sandoz (Princeton, N.J.) to announce a voluntary recall of the lots on March 21.
The nitrosamine impurity detected (N-methyl-N-nitroso-2-[(2-methylphenyl)phenylmethoxy]ethanamine [NMOA or Nitroso-Orphenadrine]) may potentially be consumed at a level higher than the Food and Drug Administration’s Acceptable Daily Intake of 26.5 ng/day. Nitrosamines have carcinogenic potency when present above the allowable exposure limits, according to Sandoz, but the company said it “has not received any reports of adverse events related to the presence of a nitrosamine impurity in the lot.”
The Orphenadrine Citrate 100 mg ER Tablets were shipped to customers from August 2019 to April 2021 and have lot numbers of JX6411, JX6413, KC0723, KC3303, KE4348, KE7169, KE4349, KL3199, KM0072, KS3939, LA7704, LA7703, and LA9243.
The lots contain 100- and 1,000-count bottles of Orphenadrine Citrate ER Tablets, which are used as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute painful musculoskeletal conditions.
The recall does not apply to any other strengths of Sandoz’s Orphenadrine Citrate ER Tablets or to other lot numbers of the product.
Sandoz advises that wholesalers and distributors should “immediately stop distribution of the recalled product and quarantine and return all recalled product in their inventory.” The company advises consumers to stop taking the recalled product and immediately consult with their physicians to obtain another prescription, notifying them of any problems that may be related to taking or using the tablets.
Sandoz says that retailers and consumers should contact Sedgwick directly by phone at 844-491-7869 or email at sandoz4887@sedgwick.com to return the recalled product, and report adverse reactions to Sandoz by phone at (800) 525-8747 or by email at qa.drugsafety@sandoz.com. Adverse reactions and quality problems can be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, or by fax to 1-800-FDA-0178.
A version of this article first appeared on Medscape.com.