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
Reported: June 11, 2025 Initiated: May 28, 2025 #D-0457-2025
Product Description
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
Reason for Recall
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 20,648 bottles
- Distribution
- US Nationwide.
- Location
- Weston, FL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apotex Corp.. Units affected: 20,648 bottles.
Why was this product recalled? ▼
Defective Container: This recall is being initiated due to a leaking unit stored horizontally.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on June 11, 2025. Severity: Moderate. Recall number: D-0457-2025.
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