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,

FDA recall notice · announced October 14, 2020 · Vistapharm

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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

Notes

Distribution: Distributed Nationwide in the USA including Puerto Rico
Lot/code information: Lots: 638800 Exp 10/21
Quantity: 14,244 16 oz bottles
Status: Terminated
Products in this recall event:
- 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 666890 (D-0019-2021)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.