Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
Reported: February 8, 2017 Initiated: January 18, 2017 #D-0463-2017
Product Description
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
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
- 7,404 unit dose cups
- Distribution
- Nationwide
- Location
- Largo, FL
Frequently Asked Questions
What product was recalled? ▼
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.. Recalled by VistaPharm, Inc.. Units affected: 7,404 unit dose cups.
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-0463-2017.
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