Denison Pharmaceuticals recalls Colic Calm medicine due to non-food grade lubricant used in production. This could pose a health risk if ingested. Consumers should check product lot numbers and contact the company for details.
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Denison Pharmaceuticals is recalling Colic Cal: a homeopathic medicine for colic, gas, and reflux. The product was made using non-food grade lubricant, which could be harmful if ingested.
The medicine was produced using non-food grade lubricant, which could be harmful if accidentally ingested. This is a manufacturing issue that occurred during production.
Parents or caregivers of infants using this medicine are most at risk. The product was sold through Ketomi LLC in Sarasota, Florida.
Check for the product name 'Colic Calm, Colic, Gas & Reflux' and the lot number 8290V. The expiration date is October 2023.
Look for the lot number 8290V and expiration date of October 2023 on the bottle.
The recall states the product was made with non-food grade lubricant, which could be harmful if ingested. The manufacturer recommends checking the lot number and contacting them for details.
Check for the lot number 8290V and expiration date of October 2023 on the bottle.
The recall does not specify a remedy, so contact Denison Pharmaceuticals for further instructions.
We’ve drafted a message you can send Denison Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0773-2023 — Denison Pharmaceuticals Denison Pharmaceuticals Hello, I own a Denison Pharmaceuticals that is covered by recall D-0773-2023 from Denison Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
