FDA-Drug2024-06-26Class II
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
Denison Pharmaceuticals, LLC
Hazard
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Sold states
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Affected count
113,544 bottles
Manufactured in
1 Powder Hill Rd, N/A, Lincoln, RI, United States
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0557-2024Don't want to check this manually?
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