FDA-Drug2017-08-09Class II
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
Apace KY LLC
Hazard
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Sold states
KY
Affected count
1,483 cartons
Manufactured in
12954 Fountain Run Rd, N/A, Fountain Run, KY, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1035-2017Don't want to check this manually?
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