Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
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