Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Failed Excipient Specifications: out of specification result observed for p-Hydroxybenzoic Acid content
Lacosamide Oral Solution, USP, CV, 10mg/mL, packaged in 200 mL bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured By: HETERO LABS LIMITED, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-627-26
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 Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Reason CGMP Deviations
Reason CGMP Deviations
Reason CGMP Deviations
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