This article is more than 5 years old. Information may no longer be current.
FDA issues warning letter to maker of homeopathic eye drops
The FDA issued a warning letter to Deserving Health International, a Canadian homeopathic drug maker, for failing to implement an appropriate manufacturing process to ensure the sterility of their Symbio Muc Eye Drops 5X.
The drops, which are marketed for use in “red and irritated eyes” and “allergy eyes,” were deemed by the FDA to be at risk of microbial contamination because of “significant violations of current good manufacturing practice (CGMP) regulations.” The company also produced a product containing penicillium notatum, which could result in penicillin contamination of their other drug products, according to the letter.
The FDA placed Deserving Health International on Import Alert on Nov. 2, 2017, subsequent to a July 2017 inspection; the alert prevents adulterated drug products from being distributed in the U.S. The company agreed to cease production of the drops and issue a recall of the product in September 2017, the letter said.
The current warning letter requests the company respond to the FDA and identify how the problems will be corrected within 15 working days. Failure to correct violations can result in further FDA action, according to the letter.