Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL)…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
What was recalled
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
- Recalling firm
- Denison Pharmaceuticals, LLC
- NDC code
- 63029-103-02
- Origin
- RI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0557-2024
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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