5 FDA recalls mention Orphenadrine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Orphenadrine.
Reason CGMP Deviations:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Reason Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC…
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