FDA-Drug2017-02-08Class II
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.
VistaPharm, Inc.
Hazard
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Sold states
Nationwide
Affected count
12,059 unit dose cups
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0460-2017Don't want to check this manually?
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