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
D-1035-2017
Product summary
- Firm
- Apace KY LLC
- Event
- Event 77601
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,483 cartons
- Official record key
drug-enforcement:D-1035-2017
Official wording
Reason: Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Code information: Lot: 16710, exp 07/2018
Distribution pattern: KY
Derived failure modes
-
Labeling or packaging
Labeling; Label Mix up