Drug 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

D-0153-2024

October 23, 2023

Class I

Product summary

Firm: The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Event: Event 93224
Status: Terminated
Classification: Class I
Quantity: 3718 saleable units
Official record key: drug-enforcement:D-0153-2024

Reason: Failed Content Uniformity Specifications

Code information: Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023

Distribution pattern: Nationwide in the USA

Potency or specification failure
reason.potency_specification_failure · v1.0.0

Failed Content Uniformity Specifications