Apace KY LLC recalls Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pula…
- Recall date
- June 19, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1035-2017
- FDA classification
- Class II
- Brand / firm
- Apace KY LLC
- Sold / distributed
- KY
Why it was 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
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What 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
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