Apace KY LLC

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
0
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0544-2018Class IIAcyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per cartonFebruary 9, 2018
D-1036-2017Class IICyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured fJune 19, 2017
D-1035-2017Class IIAmantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured fJune 19, 2017
D-0811-2016Class IIIMinocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-February 12, 2016
D-1683-2012Class IIIEnalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. Run, KY 42133, NDC September 4, 2012