FDA-Drug2020-07-15Class III
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
VistaPharm, Inc.
Hazard
Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.
Sold states
United States including Puerto Rico
Affected count
14,760 bottles
Manufactured in
7265 Ulmerton Rd, Largo, FL, United States
Products
Nystatin Oral Suspension, USP 100,000 units per mL, Bubblegum Flavored, 16 fl. oz. bottle (480 mL), Shake Well Before Using, Rx Only, Manufactured by: VistaPharm, Inc., Largo, FL 33771, NDC 66689-008-16.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1378-2020Don't want to check this manually?
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