FDA Drug Class II — Moderate

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

Hazard

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

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Products

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
Brand
Denison Pharmaceuticals, LLC
UPC
Lot #: 0855, Exp. 8/31/ 2025

Units Affected

113,544 bottles

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