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, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
Lot numbers, UPCs & expiration codes
Lot 202800, NDC 66689-035-50
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-1658-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 6, 2011
- FDA report date
- Aug 29, 2012
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-1658-2012, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62893
- Address
- 7265 Ulmerton Rd
- Code information
- Lot 202800, NDC 66689-035-50
- Postal code
- 33771-4809
- Report date
- Aug 29, 2012
- Product type
- Drugs
- Recall number
- D-1658-2012
- Classification
- Class II
- Recalling firm
- VistaPharm, Inc.
- Termination date
- Nov 23, 2012
- 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, 125mg/ 5 mL, supplied in 5 mL unit dose cups, Manufactured by VistaPharm, Inc., Largo, FL --- NDC 66689-035-50
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 6, 2011
- Initial firm notification
- Letter
- Center classification date
- Aug 21, 2012