Denison Pharmaceuticals recalls Little Remedies Gas Relief Drops (Simethicone/Antigas) due to contamination with Burkholderia Cepacia from personnel error during testing. Affected products have NDC 63029-103-02 and Lot #0855.
cGMP deviations: Test results confirmed aypical Burkholderia Cepacia were a result of personnel error.
Denison Pharmaceuticals is recalling Little Remedies Gas Relief Drops (Simethicone/Antigas) because test results showed contamination with Burkholderia Cepacia due to a personnel error in the manufacturing process. This could pose a risk to consumers using the product.
The recall is due to test results confirming the presence of Burkholderia Cepacia, a type of bacteria, which was caused by a personnel error during testing. This contamination could potentially pose a health risk to consumers using the product.
People who own or use Little Remedies Gas Relief Drops (Simethicone/Antigas) with NDC 63029-103-02 and Lot #0855 are affected. Those with the product are most at risk.
Check for the product name 'Little Remedies Gas Relief Drops (Simethicone/Antigas)' in a 1 fl. oz. (30 mL) bottle with dropper. The NDC code is 63029-103-02 and Lot #0855.
Identify the NDC code 63029-103-02 and Lot #0855 on the product label.
The product was recalled due to test results confirming the presence of Burkholderia Cepacia, a type of bacteria, which was caused by a personnel error during testing.
The official recall notice does not specify a remedy or action steps for affected products.
The recall notice does not describe a specific hazard mechanism that could cause serious injury.
We’ve drafted a message you can send Denison Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0557-2024 — Denison Pharmaceuticals Denison Pharmaceuticals Hello, I own a Denison Pharmaceuticals that is covered by recall D-0557-2024 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.
