Reported Jun 26, 2024 · Terminated
Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by…
Denison Pharmaceuticals, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Denison Pharmaceuticals, LLC · 1 Powder Hill Rd · Lincoln, RI · 02865-4407
Is this the product you have?
- 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
- Lot codes and dates
Lot #: 0855Exp. 8/31/ 2025
- Amount recalled
- 113,544 bottles
Why it was recalled
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
This product could cause temporary or reversible health problems — stop using it.
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