FDA Curcumin Investigation Supports Imprimis Statement
Published: Sep 14, 2017
SAN DIEGO, Sept. 14, 2017 /PRNewswire/ -- Imprimis Pharmaceuticals, Inc. (NASDAQ:IMMY), an ophthalmology-focused pharmaceutical company, provided an update regarding the FDA MedWatch Notice issued on August 4, 2017. The FDA's letter dated September 5, 2017 to Imprimis Pharmaceuticals, states "non-pharmaceutical grade PEG 40 Castor Oil was used due to a mislabeling by the supplier." This statement is consistent with Imprimis' previous statements in its press release on August 7, 2017. The company also confirms that upon discovery of the supplier's mislabeling, it immediately terminated its business relationship with the supplier.
Mark L. Baum, CEO of Imprimis commented, "We are grateful for FDA's diligence in investigating this unfortunate incident. Imprimis scrupulously follows state and federal laws and only purchases pharmaceutical ingredients from FDA registered and FDA inspected suppliers. In this case, the supplier's mistake was exacerbated by an inaccurately written certificate to Imprimis regarding the quality of the subject ingredient. Imprimis will continue to strive to maintain the highest quality standards in our industry and will work collaboratively with the FDA and other regulatory bodies to employ best practices in order to prevent events like these from occurring again."
Baum concluded, "Coupled with the FDA registered supplier's misrepresentation is the fact that Imprimis never actually dispensed any medication to the patient referred to in the FDA's MedWatch notice. This case related to the apparent improper administration of a medication to a patient by a practitioner who prescribed the medication for one patient and summarily, and without our knowledge, gave it to a completely different patient. Regardless, Imprimis will continue to review its operating procedures and make changes where appropriate to protect patient safety."
About Imprimis Pharmaceuticals
Imprimis Pharmaceuticals, Inc. (IMMY) is a pharmaceutical company dedicated to producing and dispensing high quality innovative medications in all 50 states. The company's unique business model increases patient access and affordability to many critical medicines. Headquartered in San Diego, California, Imprimis owns and operates production and dispensing facilities located in California and New Jersey. For more information about Imprimis, please visit the corporate website at www.ImprimisRx.com.
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include the outcomes of current or pending litigation, our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Imprimis' filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at www.sec.gov. Undue reliance should not be placed on forward looking statements, which speak only as of the date they are made. Except as required by law, Imprimis undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.
Other than drugs compounded at its FDA registered outsourcing facility, all Imprimis compounded formulations may only be prescribed pursuant to a physician prescription for an individually identified patient consistent with federal and state laws.
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SOURCE Imprimis Pharmaceuticals, Inc.