FDA recall D-0153-2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · Class I · 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
Reason for recall
Failed Content Uniformity Specifications
Distribution
Nationwide in the USA
Key facts
- Status
- Terminated
- Initiation date
- 2023-10-23
- Report date
- 2023-12-27
- Termination date
- 2024-07-10
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- La Vergne, TN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0153-2024