Reported Apr 4, 2018 · Terminated
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ…
Amneal Pharmaceuticals
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 · 50 Horseblock Rd · Brookhaven, NY · 11719-9509
Is this the product you have?
- Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India
- Distributed byAmneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
- Lot codes and dates
Lot #: AP160022AP160023Exp. 05/2018AP16038AP160039AP160040Exp. 06/2018AP160076AP160077AP160078Exp. 12/2018
- Amount recalled
- 12,584 vials
Where it was sold
- Nationwide
Why it was recalled
Presence of particulate matter
This product could cause temporary or reversible health problems — stop using it.
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