Drug product

Lactulose Solution, USP 20 g/30 mL, 50 unit dose cups of 30 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-038-50.

D-0462-2017

January 18, 2017

Class II

Product summary

Firm: VistaPharm, Inc.
Event: Event 75650
Status: Terminated
Classification: Class II
Quantity: 18,437 unit dose cups
Official record key: drug-enforcement:D-0462-2017

Official wording

Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Code information: Lot No. 422800 (1Exp. 0/17), 430500 (Exp. 12/17), 424000 (Exp. 10/17), 412500 (Exp. 07/17), 405500 (Exp. 05/17), 414900 (Exp. 09/17)

Distribution pattern: Nationwide

Derived failure modes

Manufacturing or process control
reason.manufacturing_process_control · v1.0.0

CGMP Deviations
Microbial contamination
reason.microbial_contamination · v1.0.0

contaminated with Burkholderia cepacia