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Recall Observatory FDA recall evidence

Drug product

Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medtech Products Inc., Tarrytown, NY 10591, NDC 63029-103-02

D-0557-2024

May 28, 2024

Class II

Product summary

Firm
Denison Pharmaceuticals, LLC
Event
Event 94712
Status
Terminated
Classification
Class II
Quantity
113,544 bottles
Official record key
drug-enforcement:D-0557-2024

Official wording

Reason: cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

Code information: Lot #: 0855, Exp. 8/31/ 2025

Distribution pattern: Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations