Recalls / Class II
Class IID-0557-2024
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
- Brand name
- Little Remedies
- Generic name
- Simthicone
- Active ingredient
- Dimethicone
- Route
- Oral
- NDC
- 63029-103
- FDA application
- M002
- Affected lot / code info
- Lot #: 0855, Exp. 8/31/ 2025
Why it was recalled
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Recalling firm
- Firm
- Denison Pharmaceuticals, LLC
- Manufacturer
- Medtech Products Inc.
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 1 Powder Hill Rd, N/A, Lincoln, Rhode Island 02865-4407
Distribution
- Quantity
- 113,544 bottles
- Distribution pattern
- Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
Timeline
- Recall initiated
- 2024-05-28
- FDA classified
- 2024-06-17
- Posted by FDA
- 2024-06-26
- Terminated
- 2025-08-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0557-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.