The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case
Recalled December 27, 2023 · FDA recall D-0153-2024 · The Harvard Drug Group LLC
Hazard
Failed Content Uniformity Specifications · FDA Class I
Units
3718 saleable units
Sold at
Nationwide in the USA
Description
Failed Content Uniformity Specifications
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
Manufacturer(s)
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →