FOR IMMEDIATE RELEASE – September 21, 2015 – Conway, AR– US Compounding, Inc. (“USC”) is voluntarily recalling all lots of sterile products aseptically compounded and packaged by USC and that remain within expiry due to the Food and Drug Administration’s (“FDA”)_ concern over a lack of sterility assurance. The sterile products were distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015 and September 9, 2015. The recall does not pertain to any non-sterile compounded medications prepared by USC.
If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk. As USC takes the utmost care to ensure patient safety and out of an abundance of caution, then, USC is asking all patients and providers that received sterile compounded products from USC between March 14, 2015 and September 9, 2015, and that remain within expiry, to take the following actions:
- Discontinue use of the products;
- Quarantine any unused product until further instructions are received on how to return the product; and
- Contact USC at 800-718-3588 x254 or 501-327-1222 x254 from the hours of 8:30AM-5:00PM central time Monday-Friday, or e-mail at email@example.com to discuss the return of any unused sterile compounded products.
Customers with questions regarding this recall can contact USC at 800-718-3588 x254 or 501-327-1222 x254 from the hours of 8:30AM-5:00PM central time Monday-Friday, or e-mail at firstname.lastname@example.org. Customers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Providers who have dispensed any sterile product distributed by USC to a patient(s) for use outside of the provider’s office should contact the patient(s) to whom product was dispensed and advise the patient(s) of this recall.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
This recall is being conducted with the knowledge of and at the request of the FDA.
Again, USC’s primary concern is your safety and USC is taking this action out of an abundance of caution. Thank you for your support.