FDA-Drug2023-12-27Class I

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

Sold states
Nationwide in the USA
Affected count
3718 saleable units
Manufactured in
341 Mason Rd, N/A, La Vergne, TN, United States
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0153-2024

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