Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0153-2024
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Oct 23, 2023
- FDA report date
- Dec 27, 2023
- Quantity
- 3718 saleable units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Original FDA data
Every field from FDA enforcement report D-0153-2024, exactly as published.
Show all FDA fields
- City
- La Vergne
- State
- TN
- Status
- Terminated
- Country
- United States
- Event ID
- 93224
- Address
- 341 Mason Rd
- Code information
- Lot# C00099, C00115 Exp. date: 07/31/2024; C00079 Exp. date: 12/31/2023
- Postal code
- 37086-3606
- Report date
- Dec 27, 2023
- Product type
- Drugs
- Recall number
- D-0153-2024
- Classification
- Class I
- Recalling firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Product quantity
- 3718 saleable units
- Termination date
- Jul 10, 2024
- Reason for recall
- Failed Content Uniformity Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Oct 23, 2023
- Initial firm notification
- Letter
- Center classification date
- Dec 20, 2023