FDA Recall D-0153-2024
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories · La Vergne, TN
Class I — life-threatening Terminated 261 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Recall record
- Recall number
D-0153-2024- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the USA
- Recall initiated
- 2023-10-23
- Classified by FDA Center
- 2023-12-20
- FDA published
- 2023-12-27
- Terminated
- 2024-07-10
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Firm location
- La Vergne, TN