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
D-0557-2024
Product summary
- Event
- Event 94712
- Status
- Terminated
- Classification
- Class II
- Quantity
- 113,544 bottles
- Official record key
drug-enforcement:D-0557-2024
Official wording
Reason: cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Code information: Lot #: 0855, Exp. 8/31/ 2025
Distribution pattern: Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Derived failure modes
-
Manufacturing or process control
cGMP deviations