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Drug FDA Class II Terminated Contamination / non-sterility

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 Published Jun 26, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 45/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Denison Pharmaceuticals, LLC or your place of purchase with questions, and see the source record below for full details.
Reason for recall

cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.

Hazards

Burkholderia cepacia · primary

Affected products (1)

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

LITTLE REMEDIES · 113,544 bottles

NDC: 63029-103, 63029-103-01, 63029-103-02
Code info: Lot #: 0855, Exp. 8/31/ 2025

Affected areas

Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.

Timeline

  1. Initiated
    May 28, 2024
  2. Published
    Jun 26, 2024
  3. Terminated
    Aug 26, 2025
Recall number
D-0557-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.