D-0457-2017 Class II Terminated
FDA drug recall D-0457-2017 was initiated by VistaPharm, Inc. on Jan 18, 2017 and is designated Class II. Reason for recall: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. The recall status is terminated (terminated Aug 26, 2021). Affected quantity: 67,955 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- Feb 8, 2017
- Initiation Date
- Jan 18, 2017
- Termination Date
- Aug 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 67,955 bottles
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.
Distribution Pattern
Nationwide
Code Information
a) Lot No. 422600 (Exp. 10/17), 420000 (Exp. 09/17), 416100 (Exp. 08/17), 417400 (Exp. 09/17) b) Lot No. 424200 (Exp. 10/17), 415500 (Exp. 03/18)
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0457-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026