Why it was recalled
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Product 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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1429-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 2, 2014
- FDA report date
- Jul 16, 2014
- Quantity
- 728,880 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-1429-2014, exactly as published.
Show all FDA fields
- City
- Melrose Park
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 68152
- Address
- 2045 Cornell Ave
- Code information
- 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
- Postal code
- 60160-1002
- Report date
- Jul 16, 2014
- Product type
- Drugs
- Recall number
- D-1429-2014
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 728,880 vials
- Termination date
- May 24, 2016
- Reason for recall
- Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- May 2, 2014
- Initial firm notification
- Letter
- Center classification date
- Jul 9, 2014