FDA recall D-1035-2017

Apace KY LLC · Class II · drug

Product

Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0069-15

Reason for recall

Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg

Distribution

Key facts

Status: Terminated
Initiation date: 2017-06-19
Report date: 2017-08-09
Termination date: 2018-05-04
Voluntary/Mandated: Voluntary: Firm initiated
Location: Fountain Run, KY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1035-2017