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Apace Packaging LLC is voluntarily recalling one lot each of cyclobenzaprine and amantadine 50-count unit dose boxes due to mislabeling concerns. Cyclobenzaprine 5 mg tablets (NDC 50268-0190-15) may have been mislabeled as amantadine 100 mg capsules (NDC 50268-0069-15) on the box label. The label on the unit dose blister cards inside the box contains the correct drug information. Cyclobenzaprine is a skeletal muscle relaxant used to treat muscle spasms. Concomitant cyclobenzaprine may enhance or exacerbate the sedation effects of alcohol and other central nervous system depressants. Cyclobenzaprine may cause serotonin syndrome when taken with other serotonergic drugs such as selective serotonin reuptake inhibitors (SSRIs), tricyclic antidepressants (TCAs), serotonin norepinephrine reuptake inhibitors (SNRIs), MAO inhibitors, bupropion, tramadol, verapamil, or meperidine. Amantadine is an antiviral agent used in treating Parkinson disease and some viral conditions. Patients with Parkinson disease who miss doses of or suddenly discontinue amantadine may develop a parkinsonian crisis (ie, a sudden clinical deterioration).
Apace Packaging LLC emailed distributors and customers to arrange for the return of the affected cyclobenzaprine and amantadine packages. The affected products were distributed to R&S Northeast and nationwide. Only 50-count unit dose packages are recalled. The lot number of both products is lot 16710 with an expiration date of July 2018. Consumers with questions about the recall may contact Apace Packaging (phone number 270-434-2722). Consumers who suspect they experienced harm or other issues with these products should contact their prescriber. Apace is not aware of any adverse events due to this recall. Report any adverse events to the FDA MedWatch Adverse Event Reporting Program.
Additional Information:
- MedWatch Safety Alert – July 28, 2017
www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm569056.htm - Apace Packaging press release – July 27, 2017
www.fda.gov/Safety/Recalls/ucm568875.htm