Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.

FDA recall notice · announced July 15, 2020 · Vistapharm

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

The product

Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99.

Reason for recall

Failed impurities/degradation products; Presence of an impurity peak that exceeds the approved specification.

Notes

Distribution: United States including Puerto Rico
Lot/code information: Lot #: a) 619800, Exp. 12/31/2020; 626200, Exp. 01/31/2021; b) 619800X,Exp. 12/31/2020; 626200X, Exp. 01/31/2021.
Quantity: 380,700 cups
Status: Terminated
Products in this recall event:
- 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- (D-1378-2020)
- Nystatin Oral Suspension, USP 500,000 units/5mL Cup, Delivers 5 mL, Rx Only, Manufactured by: VistaPharm, Largo, FL 33771, a) NDC 66689-037-50 (individual cup NDC: 66689-037-01); b) 66689-037-99. (D-1377-2020)

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