Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # AP160016; Exp. 05/18
- 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:
- Amneal Pharmaceuticals LLC
- Reason for Recall:
- Presence of Particulate Matter
- 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. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
Product Codes/Lot Numbers:
Lot # AP160016; Exp. 05/18
Distribution:
Distributed in: MS, NC, OH, TX, UT
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0076-2018
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