FDA recall D-0557-2024

Denison Pharmaceuticals, LLC · Class II · drug

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

Reason for recall

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

Distribution

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

Key facts

Status
Terminated
Initiation date
2024-05-28
Report date
2024-06-26
Termination date
2025-08-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Lincoln, RI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0557-2024