The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories: Drug Recall
Recall #D-0153-2024 · 10/23/2023
Class I: Dangerous
Recall Details
- Recall Number
- D-0153-2024
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Status
- Terminated
- Date Initiated
- 10/23/2023
- Location
- La Vergne, TN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3718 saleable units
Reason for Recall
Failed Content Uniformity Specifications
Product Description
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
Distribution Pattern
Nationwide in the USA
Other Recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
View all recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.