Little Remedies Gas Relief Drops recall: CGMP Deviations
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
Why was Little Remedies Gas Relief Drops recalled?
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 0855, Exp. 8/31/ 2025
- 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
- Recalling firm
- Denison Pharmaceuticals, LLC
- Quantity
- 113,544 bottles
- Distribution
- Recalled units were distributed to one customer. 100% recovered (113,544 units) and controlled at Denison Pharmaceuticals.
- Recall date
- June 26, 2024
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)