FDARecalled Dec 27, 2023 · #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
Hazard
Class I — serious health risk
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Failed Content Uniformity Specifications Classification: Class I Distribution: Nationwide in the USA
Product details
- Product
- 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
- Type
- Drugs
- Manufacturer
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Model numbers
- C00099
- UPCs
- —