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
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
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-0153-2024Don't want to check this manually?
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