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Apace Packaging LLC labeling error initiates national recall of cyclobenzaprine HCL and amantadine HCL (Lot 16710).
Apace Packaging LLC has initiated a market-level recall of a single lot of Cyclobenzaprine HCl Tablet, USP 5 mg 50ct Unit Dose, NDC# 50268-190-15, Lot Number 16710, and Amantadine HCl Capsule, USP 100 mg 50ct Unit Dose NDC# 50268-069-15, Lot Number 16710 because of a possible error in labeling, the company announced on July 27, 2017. The mislabeling is stated to have occurred in a small quantity of Cyclobenzaprine HCl Tablets USP 5 mg UD Blister Cards containers labeled as Amantadine HCl Capsules, USP 100 mg. The unit dose blister inside the containers is accurately listed as Cyclobenzaprine HCl Tablet, USP 5 mg.
Cyclobenzaprine HCl is used to relieve muscle spasms and Amantadine HCl is used for the treatment of Parkinson’s and drug-induced extrapyramidal reactions and the treatment of various viral-based conditions. Incorrect dosages of Cyclobenzaprine HCl have been linked to a deadly serotonin syndrome when combined with drugs including but not limited to serotonin norepinephrine reuptake inhibitors (SNRIs), selective serotonin reuptake inhibitors (SSRIs), and monoamine oxidase (MAO) inhibitors. Amantadine HCl has been reported to have adverse physiological effects when dosages are stopped abruptly. The company has not received any reports of negative events connected to this recall.
The affected lot of Cyclobenzaprine and Amantadine has an expiration date of July 2018. The recalled products were distributed to R&S Northeast, and then further distributed nationwide. Consumers are advised to contact their physician or healthcare provider with questions and concerns regarding this product. Adverse reactions can be reported to FDA via its website.