Class II · Moderate risk Terminated
Extended Phenytoin Sodium Capsules, USP, 100 mg, 100-count bottle, Distributed by Amneal Pharmaceuticals LLC Bridgewater, NJ…
Reason Failed Dissolution Specifications
Is Phenytoin recalled?
19 FDA recalls mention Phenytoin. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Phenytoin.
Class I · High risk Terminated
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC…
Reason Failed Content Uniformity Specifications
Class II · Moderate risk Terminated
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC…
Reason Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Class III · Low risk Terminated
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx…
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk Terminated
Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC 42192-614-10, Rx only…
Reason Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class I · High risk Terminated
Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only Mfd. by: Taro Pharmaceuticals Industries Ltd. Haifa…
Reason Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
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
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
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL…
Reason CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Class II · Moderate risk Terminated
Extended Phenytoin Sodium Capsules, USP, 100 mg Capsules, Packaged as A) 100 Count Bottles (NDC: 64679-720-01) and B) 1000 Count…
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
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
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm…
Reason Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month…
Class II · Moderate risk Terminated
Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 ---…
Reason Failed dissolution specifications; 18 month CRT
Class II · Moderate risk Terminated
PHENYTOIN SODIUM ER, Capsule, 30 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00071374066.
Reason Labeling: Label Mixup: PHENYTOIN SODIUM ER, Capsule, 30 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet…
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.
Class II · Moderate risk Terminated
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Reason Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and…
Class II · Moderate risk Terminated
Xactdose Phenytoin Oral Suspension, USP, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo…
Reason Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and…
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