The FDA has announced the voluntary recall for Reliable Drug Pharmacy compounding products due to mislabeling. Many of these products have been distributed to medical professionals, patients, and veterinarians in California, New Mexico, Hawaii, and Michigan. As a result, this group has been put on alert to check their supplies for any products labeled as Reliable Drug or Reliable Compounding Pharmacy.
Following two reports of individuals becoming severely ill after taking a drug labeled to have biotin as an ingredient, the FDA performed an inspection. The FDA collected a drug sample from one of the ill individuals and random product samples from Reliable Drug that were labeled to contain biotin. FDA investigators and the California Board of Pharmacy inspectors found very significant deficiencies in the control and distribution of products.
Any compounding products produced and distributed from the San Francisco location are under close evaluation for the mislabeling of drugs. These compounding products have biotin listed as an ingredient but contain 4-aminopyridine (4-AP, fampridine, dalfampridine) instead. 4-aminopyridine, if taken at the wrong dose or not as prescribed, can have very serious side effects, such as seizures. The FDA has been unable to confirm that the mislabeling is limited only to drugs labeled to have biotin as an ingredient. Recommendations have been made to all health professionals, patients, or pet owners to avoid the use of any compounded drugs produced by Reliable Drug. Reliable Drug stated their company would cease all compounding operations until the source of the problem is found and take necessary action to remedy it.
If you or someone you know has been injured due to a recalled drug, contact one of the experienced attorneys at Abraham, Watkins, Nichols, Agosto, Aziz & Stogner for a free consultation by calling (713) 222-7211 or toll free at 713-222-7211.