PlainRecalls
FDA Drug Low Class III Terminated

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,

Reported: October 14, 2020 Initiated: September 25, 2020 #D-0019-2021

Product Description

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

Details

Recalling Firm
VistaPharm, Inc.
Units Affected
14,244 16 oz bottles
Distribution
Distributed Nationwide in the USA including Puerto Rico
Location
Largo, FL

Frequently Asked Questions

What product was recalled?
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,. Recalled by VistaPharm, Inc.. Units affected: 14,244 16 oz bottles.
Why was this product recalled?
Failed Impurties/Degradation Specifications: out of specification results for an impurity for one lot
Which agency issued this recall?
This recall was issued by the FDA Drug on October 14, 2020. Severity: Low. Recall number: D-0019-2021.