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Recall Observatory FDA recall evidence

Drug product

Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50

D-1052-2017

June 26, 2017

Class II

Product summary

Firm
VistaPharm, Inc.
Event
Event 77638
Status
Terminated
Classification
Class II
Quantity
6150 cases
Official record key
drug-enforcement:D-1052-2017

Official wording

Reason: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

Code information: Lot #: 468300, Exp 09/2018; 474400, Exp 11/2018

Distribution pattern: CA, IL, LA, NH, OH, PA, SC

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination