China NMPA Product Recall - Physiological seawater nasal spray

Shenyang Dade Medical Device Products Co., Ltd. initiated a voluntary Class III recall of its physiological saline nasal sprays, publicly reported on October 29, 2019, by the National Medical Products Administration (NMPA) and the Liaoning Provincial Drug Administration. The core issue driving this action was a quality deviation where the product's pH value did not conform to the specified technical requirement, which mandates a pH range of 5.5 to 7.0. The company identified this non-compliance internally, leading to its proactive decision to recall the affected medical devices, registered under Liaoning Medical Device Registration 20162660169. A Class III recall signifies that exposure to the product is not likely to cause serious adverse health consequences. While specific inspection dates are not detailed, the company's self-identification of the pH discrepancy prompted this regulatory action under the NMPA's oversight. This event highlights the critical importance of rigorous quality control and adherence to product specifications within China's medical device sector, with further product-specific details available in an accompanying recall report.