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

FDA recall notice · announced December 27, 2023 · The Harvard Drug Group Llc Dba Major Pharmaceuticals And Rugby Laboratories

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Reason for recall

Failed Content Uniformity Specifications

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
Quantity: 3718 saleable units
Status: Terminated
Products in this recall event:
- 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 (D-0153-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.