Apace KY recalls
FDA enforcement reports naming Apace KY LLC as the recalling firm.
- Recall reports
- 5
- Class I (serious)
- 0
- Most recent report
- Mar 7, 2018
- Mar 7, 2018Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-1…Drug · Apace KY LLCPresence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.Class II
- Aug 9, 2017Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, M…Drug · Apace KY LLCLabeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mgClass II
- Aug 9, 2017Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, M…Drug · Apace KY LLCLabeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mgClass II
- Apr 13, 2016Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blister…Drug · Apace KY LLCLabeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.Class III
- Sep 26, 2012Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, FtDrug · Apace KY LLCLabeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.Class III