Class II · Moderate risk Terminated
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807…
Reason Presence of particulate matter
Is Fosphenytoin recalled?
6 FDA recalls mention Fosphenytoin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Fosphenytoin.
Class II · Moderate risk Terminated
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal…
Reason Presence of Particulate Matter
Class II · Moderate risk Terminated
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx…
Reason Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class II · Moderate risk Terminated
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx…
Reason Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Class II · Moderate risk Terminated
Fosphenytoin Sodium Injection, USP, 500 mg PE per 10 mL (50 mg PE per mL), 10 mL Single Dose Vial, packaged in 10-count x 10 mL…
Reason Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Class II · Moderate risk Terminated
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 2 mL…
Reason Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
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