MedicineWatch US
Class I Recall

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

Product
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 0904-7079-57), Rx only, Major Pharmaceuticals Livonia, MI 48152
Reason
Failed Content Uniformity Specifications
Classification
Class I
Status
Terminated
Lot
Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.