Taro Pharmaceuticals U.S.A., Inc. has recalled one lot of corticosteroid Clobetasol Propionate in the form of ointment for the potential presence of Ralstonia pickettii bacteria, the U.S. Food and Drug Administration or FDA said in a statement.
The recall involves one lot containing 96 units of Clobetasol Propionate Ointment USP, 0.05% packaged in 60 g aluminum tubes with polypropylene puncture-tip caps. The company noted that the recall only applies to tubes labeled with “Lot AC13786” and “Exp Dec 2022”. No other lots of this product are impacted.
The presence of the bacteria was discovered by the manufacturer through routine testing. Clobetasol Propionate Ointment is indicated for the relief of inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.
Ralstonia pickettii bacteria is present in the natural environment in soil and water. The product contamination with the bacteria may lead to systemic infections due to the presence of the corticosteroid component which enhances absorption of the ointment in individuals who are immunocompromised, or whose skin is not intact.
Further, 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.
The FDA warned that consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
However, the company has not received reports of any adverse events associated with this issue for the recalled lot, which were distributed to two wholesale distributors in the U.S. market between November 16 and December 6, 2021. These two wholesale distributors may have further distributed this lot to their retail customers for prescription dispensing to patients.
The Hawthorne, New York-based company urged anyone with an existing inventory of the recalled lot to stop distribution and return any unsold units to their wholesaler. It has notified the affected distributors and is arranging for return of any containers of the ointment.
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