Why it was recalled
Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
Product description
Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
Lot numbers, UPCs & expiration codes
Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
Where it was sold
Nationwide
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-1440-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 30, 2011
- FDA report date
- Aug 8, 2012
- Quantity
- 27,221 unit dose cups
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-1440-2012, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62421
- Address
- 7265 Ulmerton Rd
- Code information
- Lot #'s 210900, 214000, 220100, 224800, 228700, 232800
- Postal code
- 33771-4809
- Report date
- Aug 8, 2012
- Product type
- Drugs
- Recall number
- D-1440-2012
- Classification
- Class II
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 27,221 unit dose cups
- Termination date
- Dec 12, 2013
- Reason for recall
- Defective container; lidding deformity allows the contained product to transpire causing potential viscosity and assay failures. The viscosity and assay failures were due to the loss of moisture. The loss of moisture caused the viscosity to increase and assay to increase relative to the sample volume.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Xactdose Phenytoin Oral Suspension, USP 125 mg/5mL, supplied in 5 mL unit dose cups, VISTAPHARM, Largo, FL NDC 66689-036-50
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 30, 2011
- Initial firm notification
- Letter
- Center classification date
- Aug 2, 2012