Colic Calm recall: CGMP Deviations
Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
Why was Colic Calm recalled?
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 8290V, Exp: 10-2023
- Product
- Colic Calm, Colic, Gas & Reflux, Homeopathic Medicine, 2 Fl. Oz (59 ml) bottle. Distributed by Ketomi LLC, 1215 Sarasota Center Blvd., Sarasota FL 34240.
- Recalling firm
- Denison Pharmaceuticals, LLC
- Quantity
- 54,222 bottles
- Distribution
- Product was distributed Nationwide.
- Recall date
- June 7, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)