Class II
Terminated
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
- Company
- Denison Pharmaceuticals, Llc
- Recall Initiated
- May 28, 2024
- Posted
- June 26, 2024
- Recall Number
- D-0557-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 113,544 bottles
- Firm Location
- Lincoln, RI, United States
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.
Lot / Code Info
Lot #: 0855, Exp. 8/31/ 2025
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