Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14 6004554; 08/14 6004588; 09/14 6004589; 09/14 6005201; 12/14 6005202; 12/14 6005293; 12/14 6005294; 12/14 6005545; 02/15 6005546; 02/15 6005831; 03/15 6005832; 03/15 6005973; 04/15 6005974; 04/15 6006035; 05/15 6006036; 05/15 6006037; 05/15 6006174; 05/15 6006175; 05/15 6006176; 06/15 6006449; 07/15 6006450; 07/15 6006451; 07/15 6007168; 11/15
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Fresenius Kabi USA, LLC
- Reason for Recall:
- Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10
Product Codes/Lot Numbers:
Lot # 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14 6004554; 08/14 6004588; 09/14 6004589; 09/14 6005201; 12/14 6005202; 12/14 6005293; 12/14 6005294; 12/14 6005545; 02/15 6005546; 02/15 6005831; 03/15 6005832; 03/15 6005973; 04/15 6005974; 04/15 6006035; 05/15 6006036; 05/15 6006037; 05/15 6006174; 05/15 6006175; 05/15 6006176; 06/15 6006449; 07/15 6006450; 07/15 6006451; 07/15 6007168; 11/15
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1429-2014
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