China NMPA Product Recall - Ambroxol Hydrochloride Injection

On November 27, 2017, Shanghai Boehringer Ingelheim Pharmaceuticals Co., Ltd., acting as the distributor and labeler for Boehringer Ingelheim Espana, S. A., initiated a voluntary recall in China for specific batches of its Ambroxol Hydrochloride Injection (Mucosolvan®). This action was reported to the National Medical Products Administration (NMPA). The recall stemmed from internal stability testing of retained samples from the Spanish manufacturing facility, which revealed elevated levels of a specific substance. Crucially, all detected levels remained within the product's established quality standards, and Boehringer Ingelheim's assessment indicated no identified risk to patients from the affected batches. The company emphasized this was a precautionary voluntary measure to maintain its commitment to quality. The recall was not prompted by external inspection dates but rather by internal quality control processes. Under the NMPA's oversight, the required action involves the withdrawal of numerous identified repackaging and product batches, including, but not limited to, batches 727075/A81513 and 727070/A82134, from the Chinese market to ensure product integrity and consumer confidence.