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
Reported: August 9, 2017 Initiated: June 19, 2017 #D-1035-2017
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
Details
- Recalling Firm
- Apace KY LLC
- Units Affected
- 1,483 cartons
- Distribution
- KY
- Location
- Fountain Run, KY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apace KY LLC. Units affected: 1,483 cartons.
Why was this product recalled? ▼
Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 9, 2017. Severity: Moderate. Recall number: D-1035-2017.
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