Muscle Spasm and Parkinson’s Drugs Recall; Deadly Syndrome

On July 28, 2017, Apace Packaging LLC recalled one lot of Cyclobenzaprine HCl Tablets and one lot of Amantadine HCl Capsules due to potential mislabeling. A small number of cartons containing Cyclobenzaprine HCl Tablets 5 mg UD Blister Cards may be mislabeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blisters inside the carton are correctly labeled as Cyclobenzaprine HCl Tablet, USP 5 mg.


Cyclobenzaprine HCl is used for the relief of muscle spasms. Unintentional dosing with Cyclobenzaprine HCl may potentially lead to the development of life-threatening serotonin syndrome, which has been reported with Cyclobenzaprine HCl when used in combination with other drugs, such as selective serotonin reuptake inhibitors (SSRIs), serotonin norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), tramadol, bupropion, meperidine, verapamil, or MAO inhibitors. The effects of alcohol, barbiturates, and other CNS depressants may be enhanced, and may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle.


Amantadine HCl is used for the treatment of Parkinson’s; extrapyramidal symptoms (EPS), also known as extrapyramidal side effects (EPSE), drug-induced movement disorders that include acute and tardive symptoms; and various viral-based conditions. Amantadine has a precaution in its prescribing indication about the abrupt discontinuation of the medicine. Missed doses of Amantadine in a few patients with Parkinson’s disease have resulted in a parkinsonian crisis, i.e., a sudden marked clinical deterioration, when this medication was suddenly stopped.


The recalled products are packaged in 50-count hospital unit dose cartons (10 unit doses per card, 5 cards per carton). The recalled Cyclobenzaprine HCl 5mg tablets have an NDC number of 50268-190-15. The recalled Amantadine HCl 100mg capsules have an NDC number of 50268-069-15. Recalled lot number is 16710 and has an expiration date of 07/2018. The recalled products were distributed nationwide.


See the FDA Safety Alert


See the Recall


See also Medical Law Perspectives Report: Drugs, Dosage, and Damage: Physician Liability for Prescribing or Administering Medication