[3/30/2016] The U.S. Food and Drug Administration (FDA) is alerting health care professionals, patients, and pet owners of a voluntary recall of all unexpired compounded drug products produced and distributed by Reliable Drug Pharmacy in San Francisco, due to concerns over mislabeled compounded drug products. The recalled products were compounded for human and animal use and were distributed between March 24, 2015, and March 24, 2016.
Health care professionals, including veterinarians, patients, and pet owners should immediately check their medical supplies and quarantine any compounded drug products produced by Reliable Drug. Patients and pet owners should contact their health care professional before stopping the medication.
The recalled products are labeled as: Reliable Drug or Reliable Compounding Pharmacy.
During an inspection, FDA investigators and California Board of Pharmacy inspectors observed significant deficiencies in the firm’s conditions and controls for producing compounded drug products. Therefore, FDA cannot confirm the identity, strength, quality, or purity of any compounded drug products produced at the facility.
To date, FDA has received two human adverse event reports from patients taking drug products labeled as biotin that were compounded by Reliable Drug. The biotin capsules associated with the adverse event reports were made by Reliable Drug between January 15 and March 3, 2016.
FDA collected biotin capsule samples on March 16, 2016, from one of the patients who had reportedly experienced adverse events associated with use of the product. On March 18, 2016, FDA collected additional samples of drug products labeled as biotin from Reliable Drug. FDA’s analysis of the samples revealed that these drug products did not contain biotin as labeled, but rather contained 4-aminopyridine (4-AP, fampridine, dalfampridine), which can have serious consequences such as seizures, especially if taken in the wrong amounts or not as prescribed.
At this time, FDA cannot confirm that Reliable Drug’s mislabeling is limited to drug products labeled as biotin. Therefore FDA recommends that health care professionals, patients, and pet owners avoid use of all compounded drug products produced by Reliable Drug. On March 25, 2016, Reliable Drug informed FDA that it would cease all compounding operations until the facility implements appropriate corrective actions.
Patients and pet owners who have received compounded drug products produced by Reliable Drug and have concerns should contact their health care professional.
FDA encourages health care professionals and patients to report adverse reactions or quality issues experienced with the use of human drug products to FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm; or
- Download and complete the form, then submit it via fax at 1-800-FDA-0178.
To date, FDA has not received reports of adverse event in animals. Pet owners and veterinarians can report complaints about animal drug products by calling the consumer complaint coordinator in their area or by filing a Veterinary Adverse Drug Reaction report. For more information, see How to Report Animal Drug Side Effects and Product Problems.
FDA will continue working with the California Board of Pharmacy to protect the public health, investigate this issue, and provide further information when it is available.