Medicine recalls
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| The United States: Taro Pharmaceuticals U.S.A. issues voluntary nationwide recall of Clobetasol Propionate Ointment USP, 0.05%, 60 g tubes, lot AC13786 due to microbial contamination |
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The US Food and Drug Administration (FDA) announces that Taro Pharmaceuticals U.S.A., Inc. is voluntarily recalling one lot of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g tubes, to the consumer level. This recall only applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product are impacted. Lot AC13786 is being recalled due to the presence of Ralstonia pickettii bacteria (R. pickettii), which was discovered by the manufacturer through routine testing.
R. pickettii is present in the natural environment (soil, water) and for healthy individuals with intact skin, is unlikely to cause any localized or systemic infections. However, for individuals who are immunocompromised, or whose skin is not intact (i.e. sunburn, psoriasis, abrasions), there is a reasonable possibility that systemic infections may occur if the product is contaminated with R. pickettii due to the presence of the corticosteroid component which enhances absorption of the ointment. If this bacterium is circulating in the human blood stream it can cause life-threatening, invasive infections such sepsis, pneumonia, meningitis, inflammation of the bone or bone marrow, and infection in the joint fluid and joint tissues. To date, Taro has not received any adverse event reports related to this lot.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/taro-pharmaceuticals-usa-issues-voluntary-nationwide-recall-clobetasol-propionate-ointment-usp-005
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Friday, Dec 31, 2021
Issued at HKT 15:00
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