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Recall Observatory FDA recall evidence

Drug product

Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz), Cherry Flavor, 10 FL OZ (296 mL), Distributed By Topco Associates LLC Elk Grove Village, IL 60007; NDC 36800-164-38 UPC 0 36800 45530 6

D-1508-2022

July 15, 2022

Class I

Product summary

Firm
Vi-Jon, LLC
Event
Event 90599
Status
Terminated
Classification
Class I
Quantity
18,588 bottles
Official record key
drug-enforcement:D-1508-2022

Official wording

Reason: Microbial contamination of non-sterile products.

Code information: Lot # 0546394, EXP 9/29/2023

Distribution pattern: Distributed Nationwide in the USA as well as Canada and Panama.

Derived failure modes

  • Microbial contamination

    reason.microbial_contamination · v1.0.0

    Microbial contamination