Denison Pharmaceuticals, LLC recalls Little Remedies Gas Relief Drops (Simethicone/Antigas), packaged in 1 fl. oz. (30 mL) bottle with dropper, Dist by Medte
Recalled June 26, 2024 · FDA recall D-0557-2024 · Denison Pharmaceuticals
Hazard
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error. · FDA Class II
Units
113,544 bottles
Sold at
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Description
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Product
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
Manufacturer(s)
Denison Pharmaceuticals, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →