Colic Calm Homeopathic Medicine Recalled for Manufacturing Contamination
Denison Pharmaceuticals is recalling Colic Calm, a homeopathic medicine, due to non-food grade lubricant used in the mixing vessel during manufacturing. Affected lot 8290V was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The use of non-food grade lubricant in manufacturing represents a potential health hazard for a medication product, satisfying the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Denison Pharmaceuticals, LLC is recalling Colic Calm, a homeopathic medicine for colic, gas, and reflux. The product is supplied in 2 fluid ounce (59 ml) bottles and was distributed by Ketomi LLC of Sarasota, Florida.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, a non-food grade lubricant was used in the mixing vessel during the product's manufacture, which could result in product contamination.
Lot 8290V with an expiration date of October 2023 is affected. Approximately 54,222 bottles of the product were distributed nationwide.
The recalled product
- 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.
- Manufacturer
- Denison Pharmaceuticals, LLC
- Category
- Drug — Homeopathic Medicine
- Affected units
- 54,222
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 8290V
- Exp: 10-2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Denison Pharmaceuticals, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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