Recalling firm
Denison Pharmaceuticals, LLC
Product type
Drug
Status
Terminated
Report date
2024-06-26
Distribution
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Firm state
RI
Product quantity
113,544 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Risk Management & CAPAReason for recall
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Product description
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
Code / lot info
Lot #: 0855, Exp. 8/31/ 2025
Other recalls SPEQ maps to Risk Management & CAPA
See all Risk Management & CAPA recalls →Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.