Nitrosamine Impurity Detected in Certain Lots of Orphenadrine Citrate ER Tablets
Sandoz is voluntarily recalling 13 lots of Orphenadrine Citrate 100mg extended-release (ER) tablets to the consumer level due to the presence of a nitrosamine impurity, NMOA or nitroso-orphenadrine, above the Food and Drug Administration’s (FDA)…