Fosphenytoin Sodium Injection recall: Particulate Matter
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
Why was Fosphenytoin Sodium Injection recalled?
Presence of Particulate Matter
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # AP160016; Exp. 05/18
- Product
- 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
- Recalling firm
- Amneal Pharmaceuticals LLC
- Quantity
- 14,000 vials
- Distribution
- MS, NC, OH, TX, UT
- Recall date
- November 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)