Home / Recalls / Apace KY LLC / D-1035-2017

D-1035-2017 Class II Terminated

Recalled by Apace KY LLC — Fountain Run, KY

Recall Details

Product Type
Drugs
Report Date
August 9, 2017
Initiation Date
June 19, 2017
Termination Date
May 4, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,483 cartons

Product Description

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 Pattern

KY

Code Information

Lot: 16710, exp 07/2018

Other recalls by Apace KY LLC

  • D-0544-2018 Class II — Acyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 5026 (February 9, 2018)
  • D-1036-2017 Class II — Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx (June 19, 2017)
  • D-0811-2016 Class III — Minocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose (February 12, 2016)
  • D-1683-2012 Class III — Enalapril Maleate Tablet, USP 5mg 30 Tablet bottle, Rx, Apace Packaging LLC, Ft. (September 4, 2012)