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
Reported: December 27, 2023 Initiated: October 23, 2023 #D-0153-2024
Product Description
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
Reason for Recall
Failed Content Uniformity Specifications
Details
- Units Affected
- 3718 saleable units
- Distribution
- Nationwide in the USA
- Location
- La Vergne, TN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories. Units affected: 3718 saleable units.
Why was this product recalled? ▼
Failed Content Uniformity Specifications
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 27, 2023. Severity: Critical. Recall number: D-0153-2024.
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