Reported Dec 27, 2023 · Terminated

Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per…

The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · 341 Mason Rd · La Vergne, TN · 37086-3606

Is this the product you have?

  • 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
Lot codes and dates
    • Lot# C00099
    • C00115 Exp
  • date
    • 07/31/2024
    • C00079 Exp
  • date12/31/2023
Amount recalled
3718 saleable units

Where it was sold

  • Nationwide

Why it was recalled

Stop using this product now

Failed Content Uniformity Specifications

Using this product could cause serious injury, illness or death — stop using it now.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Jul 10, 2024 · Data as of Sep 19, 8:03 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.