FDA Drug Class I — Most Serious

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

Hazard

Failed Content Uniformity Specifications

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Products

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
Brand
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
UPC
Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023

Units Affected

3718 saleable units

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