Teligent Pharma, Inc. is recalling approximately 184,200 tubes of Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), a topical steroid medication. The recall includes tubes sold directly by Teligent and those distributed by Sky Packaging. The medication is being recalled because testing revealed the presence of an impurity called Betamethasone 17-propionate at levels that exceed approved specifications. This defect was identified during stability testing, which indicates the product's quality may degrade over time. These products were distributed to pharmacies and healthcare facilities nationwide between 2021 and 2022.
The product failed to meet impurities and degradation specifications, meaning the medication may contain higher-than-allowed levels of chemical byproducts. This could potentially reduce the effectiveness of the treatment or lead to unforeseen side effects, although the risk level is currently classified as low.
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Sources: FDA iRES · Raw API Response
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