Reported Jul 16, 2014 · Terminated
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use…
Fresenius Kabi USA, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fresenius Kabi USA, LLC · 2045 Cornell Ave · Melrose Park, IL · 60160-1002
Is this the product you have?
- 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 codes and dates
30 of 30 products · 30 lot codes
Recalled lot codes, grouped by product number Product number Lot codes and dates 0414 6003855
0414 6004011
0514 6003961
0514 6004091
0614 6004092
0614 6004553
0814 6004554
0814 6004588
0914 6004589
0914 6005201
- Amount recalled
- 728,880 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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