D-0459-2017 Class II Terminated
FDA drug recall D-0459-2017 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: 3,496 unit dose cups.
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
- 3,496 unit dose cups
Product Description
Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-031-50.
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
Lot No. 428700 (Exp. 11/17), 409500 (Exp.06/17)
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0459-2017
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026