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Recall Observatory FDA recall evidence

Drug product

NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd. Nutraceutical Corp., Salt Lake City, UT, 84101 USA, UPC 3 71402 30101 0

D-0440-2023

February 23, 2023

Class II

Product summary

Firm
Nutraceutical Corporation
Event
Event 91708
Status
Ongoing
Classification
Class II
Quantity
1590
Official record key
drug-enforcement:D-0440-2023

Official wording

Reason: CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Code information: Lot 222148, Exp: 05/25;

Distribution pattern: Nationwide in the USA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations