D-0557-2024 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- June 26, 2024
- Initiation Date
- May 28, 2024
- Termination Date
- August 26, 2025
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 113,544 bottles
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
Reason for Recall
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Distribution Pattern
Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Code Information
Lot #: 0855, Exp. 8/31/ 2025