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FDA Alert: Sandoz, Inc. Issues Nationwide Recall of 13 Lots of Orphenadrine Citrate 100 mg Extended Release Tablets Due to Presence of a Nitrosamine Impurity

Drug Alerts (FDA)

U.S. Food and Drug Administration (FDA)’s Acceptable Daily Intake (ADI) limit of 26.5 ng/day, 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...