Reported Nov 22, 2017 · Terminated
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by:…
Amneal Pharmaceuticals 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: Amneal Pharmaceuticals LLC · 118 Beaver Trl · Glasgow, KY · 42141-1273
Is this the product you have?
- Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only
- Distributed byAmneal Biosciences, Bridgewater, NJ 08807
- NDC70121-1390-7
- Lot codes and dates
Lot # AP160016Exp. 05/18
- Amount recalled
- 14,000 vials
Where it was sold
Why it was recalled
Presence of Particulate Matter
This product could cause temporary or reversible health problems — stop using it.
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