The Recall Desk
HighFDA (Drugs)·D-0773-2023·Announced 2023-06-07

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
Hazard
  • non-food-lubricant
  • manufacturing-deviation

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.

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