Denison Pharmaceuticals, LLC is recalling approximately 159,618 units of several over-the-counter medications, including Colic Calm, Pin-Away pinworm treatment, Safe tussin PM, and Safe tussin DM. The recall is due to manufacturing deviations where a non-food grade lubricant was used in the mixing vessels during the production process. These products were distributed nationwide.
The use of non-food grade lubricant in mixing vessels creates a risk of chemical contamination in the medications. Consuming substances not intended for human ingestion may lead to adverse health effects, though no injuries have been reported to date.
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Distributed by Ketomi LLC, Sarasota FL.
Distributed by Cara Incorporated, Warwick, RI.
Distributed by Kramer Laboratories, Inc. Bridgewater, NJ.
Distributed by Kramer Laboratories, Inc. Bridgewater, NJ.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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