FDA Drug Shortages

Current and Resolved Drug Shortages and Discontinuations Reported to FDA

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Nystatin Oral Suspension
Status: Currently in Shortage
»Date first posted: 01/08/2019
»Therapeutic Categories: Anti-Infective; Pediatric

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Pharmaceutical Associates, Inc (New 01/08/2019)

Company Contact Information:
800-845-8210

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Nystatin Oral Suspension, USP 500,000 Units/5 mL 5 mL Unit Dose Cups Case of 40 – 5 mL UDC (NDC 00121-4810-40); Case of 100 – 5 mL UDC (NDC 00121-4810-00); 2 oz. Bottles (NDC 00121-0810-02); 16 oz. Bottles (NDC 00121-0810-16) Product availability will be limited as we resume production. Resolution of product quality and manufacturing concerns. Requirements related to complying with good manufacturing practices

VistaPharm, Inc. (New 01/08/2019)

Company Contact Information:
877-530-1633

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Nystatin Oral Suspension, USP 500,000 units/5 ml; 5mL unit dose cup; 50 unit dose cups/ case (NDC 66689-037-50) Undetermined Undetermined Requirements related to complying with good manufacturing practices
Nystatin Oral Suspension, USP 500,000 units/5 ml; 5mL unit dose cup; 100 unit dose cups/ case (NDC 66689-037-99) Undetermined Undetermined Requirements related to complying with good manufacturing practices
Nystatin Oral Suspension, USP 100,000 units/ml; 60 mL Bottle (NDC 66689-008-02) Undetermined Undetermined Requirements related to complying with good manufacturing practices
Nystatin Oral Suspension, USP 100,000 units/ml; 480 mL Bottle (NDC 66689-008-16) Undetermined Undetermined Requirements related to complying with good manufacturing practices

Wockhardt (Reverified 06/12/2019)

Company Contact Information:
800-346-6854 ext. 2

Presentation Availability and Estimated Shortage Duration Related Information Shortage Reason (per FDASIA)
Nystatin Oral Solution 100,000 units/1mL; 473 mL bottles (NDC 60432-0537-16) Available Other
Nystatin Oral Solution 100,000 units/1mL; 60 mL bottles (NDC 60432-0537-60) Available Other

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