Why it was recalled
Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
Product description
Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
Lot numbers, UPCs & expiration codes
Lots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15
Where it was sold
Nationwide and Puerto Rico
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-342-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 15, 2013
- FDA report date
- Dec 18, 2013
- Quantity
- 27,788 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-342-2014, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 66945
- Address
- 7265 Ulmerton Rd
- Code information
- Lots #'s: 268200, Exp 06/14; 274600, Exp 08/14; 279500, Exp 09/14; 290700, Exp 12/14; 296700, Exp 02/15; 305100, Exp 06/15
- Postal code
- 33771-4809
- Report date
- Dec 18, 2013
- Product type
- Drugs
- Recall number
- D-342-2014
- Classification
- Class II
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 27,788 cases
- Termination date
- Sep 28, 2016
- Reason for recall
- Defective Container: A lidding deformity allowed for the product to have out of specification results for assay and viscosity at the12 month stability timepoint.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Phenytoin Oral Suspension USP 125mg/5mL, 50 cups per case, For Oral Administration Only, Rx Only, Manufactured by: VistaPharm Inc, Largo, FL 33771, NDC 66689-036-50
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Oct 15, 2013
- Initial firm notification
- Letter
- Center classification date
- Dec 6, 2013