FDAFDA · Food and drugs·Recall number D-0557-2024
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
Published June 26, 2024 · Recall initiated: May 28, 2024
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
What to do
Voluntary: Firm initiated
Recall details
- Brand
- LITTLE REMEDIES
- Manufacturer
- Denison Pharmaceuticals, LLC
- Distributor
- Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
- Lot
- Lot #: 0855, Exp. 8/31/ 2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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