FDA-Drug2020-10-14Class III
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
VistaPharm, Inc.
Hazard
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Sold states
Distributed Nationwide in the USA including Puerto Rico
Affected count
14,244 16 oz bottles
Manufactured in
7265 Ulmerton Rd, N/A, Largo, FL, United States
Products
NYSTATIN ORAL SUSPENSION, USP 100,000 units per mL Contains: Alcohol 0.5% v/v (Bubblegum Flavored) 16 fl. oz. (480 mL) Manufactured by: VistaPharm, Inc. Largo FL 33771, USA NDC 66689-008-16 UPC 6668900816,
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0019-2021Don't want to check this manually?
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