An Important Safety Message from Sinex
On April 29, 2009, Procter & Gamble received a letter from the U.S. Food and Drug Administration (FDA) asking us to address concerns they have with certain manufacturing practices at our plant in Cayey, Puerto Rico. There are several important points to understand about this action:
1. Vicks® Sinex® and Vicks Sinex 12 Hour Nasal Spray on the market are safe and effective when used as directed. Consumers can continue to use Vicks Sinex and Vicks Sinex 12 Hour Nasal Spray with confidence.
2. The issues raised in the FDA's letter are restricted to certain manufacturing practices at our Cayey plant in Puerto Rico, and do not relate to any other manufacturing facilities.
3. The concerns highlighted by the FDA in their inspection of our Cayey manufacturing site involve our manufacturing process, not the finished products that are in the marketplace.
4. While our existing manufacturing procedures at this facility are designed to meet industry-leading quality and safety standards that P&G demands and consumers deserve, the FDA inspection did identify potential areas where we can and will make improvements in our manufacturing processes.
5. Every batch of products that we release from our plants has passed strict quality and safety checks and we are confident that our products in the marketplace are safe.
6. Nevertheless, we are taking this matter seriously and cooperating fully with the FDA to address their concerns.
Consumers can have confidence in the quality and safety of all of our products. We are guided not only by appropriate regulatory guidelines, but also by our product safety policies and practices: http://www.pg.com/company/our_commitment/product-safety-policy-and-practices.shtml
