FDAFDA · Food and drugs·Recall number D-0460-2017
Phenytoin Oral Suspension, USP 100 mg/ 4 mL, 50 unit dose cups of 4 mL per case., Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-036-50.
Published February 8, 2017 · Recall initiated: January 18, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- VistaPharm, Inc.
- Distributor
- Nationwide
- Lot
- Lot No. 428700 (Exp. 11/17), 409500 (Exp. 06/17)
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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