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
Reported: November 22, 2017 Initiated: August 31, 2017 #D-0076-2018
Product 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
Reason for Recall
Presence of Particulate Matter
Details
- Recalling Firm
- Amneal Pharmaceuticals LLC
- Units Affected
- 14,000 vials
- Distribution
- MS, NC, OH, TX, UT
- Location
- Glasgow, KY
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Amneal Pharmaceuticals LLC. Units affected: 14,000 vials.
Why was this product recalled? ▼
Presence of Particulate Matter
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on November 22, 2017. Severity: Moderate. Recall number: D-0076-2018.
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