Leaking Heat Cells In Pfizer's ThermaCare HeatWraps Prompt Recall
This article was originally published in The Pink Sheet & The Rose Sheet
Firm's consumer health division extends to consumer level a recall it advised retailers and distributors about on Oct. 2 because products from the six lots have a potential to leak ingredients contained in heat cell wraps. A leaking heat cell in a HeatWrap could cause skin injuries such as burns, blisters or skin irritation on the applied areas.
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A problem with overheating heat cells in Pfizer's ThermaCare OTC pain-relief patch is not limited to the US market, the company has discovered, prompting recalls across four European markets.
Pfizer Consumer Healthcare division recalls one lot of ThermaCare Back Pain Therapy HeatWraps, up to 16HR pain relief, because the products could include cells that have a higher cell temperature than specified. Firm in late 2018 recalled six lots of ThermaCare HeatWraps Muscle Joint Therapy 8-hour strength due to reports of leaking heat cells.
Many of the 30 drug product firms that received FDA warning letters in 2016 were foreign cosmetics and hygiene manufacturers that appeared to need education on US GMP requirements. Another major focus in letters to drug product firms last year was sterility assurance in the US and abroad.