FDAFDA · Food and drugs·Recall number D-0153-2024
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
Published December 27, 2023 · Recall initiated: October 23, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Content Uniformity Specifications
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Distributor
- Nationwide in the USA
- Lot
- Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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