FDARecalled Jun 26, 2024 · #D-0557-2024
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
Hazard
Class II — temporary health risk
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cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error. Classification: Class II Distribution: Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Product details
- 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
- Type
- Drugs
- Manufacturer
- Denison Pharmaceuticals, LLC
- Model numbers
- 0855
- UPCs
- —