Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Reported: February 8, 2017 Initiated: January 18, 2017 #D-0457-2017
Product Description
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Reason for Recall
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Details
- Recalling Firm
- VistaPharm, Inc.
- Units Affected
- 67,955 bottles
- Distribution
- Nationwide
- Location
- Largo, FL
Frequently Asked Questions
What product was recalled? ▼
Nystatin Oral Suspension, USP 100,000 units per mL, a) 2 fl. oz. (60 mL), 24 bottles per case (NDC 66689-008-02), b) 16 fl. oz. (237 mL), 12 bottles per case (NDC 66689-008-16), Rx only, Manufactured by VistaPharm, Largo, FL 33771. Recalled by VistaPharm, Inc.. Units affected: 67,955 bottles.
Why was this product recalled? ▼
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 8, 2017. Severity: Moderate. Recall number: D-0457-2017.
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