PillFosphenytoin Sodium
Brands: Cerebyx · Fosphenytoin Sodium
6 active makers
soon
soon
soon
soon
Medicaid dispensing volumeSDUD · per quarter
Prescriptions dispensed under Medicaid (fee-for-service + managed care), summed nationally. The closest free proxy to sales volume — Medicaid only, not all-payer.
Who makes it6 active · 0 exited
US labelers as registered with FDA. Repackagers relabel another company's product; share* is of listed packages, not sales.
| Labeler | Type | Packages | Status |
|---|---|---|---|
| Pfizer Laboratories Div Pfizer Inc | unknown | 4 | SUPPLYING |
| Glenmark Pharmaceuticals Inc., USA | unknown | 3 | SUPPLYING |
| Fresenius Kabi USA, LLC | unknown | 2 | SUPPLYING |
| Sagent Pharmaceuticals | unknown | 2 | SUPPLYING |
| West-Ward Pharmaceuticals Corp | unknown | 2 | SUPPLYING |
| Gland Pharma Limited | unknown | 2 | SUPPLYING |
Regulatory & supply eventsFDA · US
Shortages, recalls, and registration changes attached to this drug concept.
- May 2, 2014RECALLRecall (Class II): Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vi…
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. — Recalling firm: Fresenius Kabi USA, LLC — Nationwide and Puerto Rico
- May 2, 2014RECALLRecall (Class II): Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use …
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials. — Recalling firm: Fresenius Kabi USA, LLC — Nationwide and Puerto Rico
- Apr 13, 2012RECALLRecall (Class II): Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count…
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. — Recalling firm: West-ward Pharmaceutical Corp. — All lots were distributed throughout the US.
- Apr 13, 2012RECALLRecall (Class II): Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x…
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. — Recalling firm: West-ward Pharmaceutical Corp. — All lots were distributed throughout the US.