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# C00099C00115 Exp
- date
07/31/2024C00079 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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