FDA recall D-0019-2021

Product

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,

Reason for recall

Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot

Distribution

Distributed Nationwide in the USA including Puerto Rico

Key facts

Status

Terminated

Initiation date

2020-09-25

Report date

2020-10-14

Termination date

2022-09-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Largo, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0019-2021