FDA Recommends Staying Away From Compounding Pharmacy
This week the FDA released a notice that a compounding pharmacy has voluntarily recalled certain human and veterinary products produced and distributed for sterile use.
“Patient safety is a top priority for the agency, and giving a patient a contaminated injectable drug could result in a life-threatening infection,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “Out of an abundance of caution, we are recommending that patients discontinue use of any sterile product produced by this firm.”
As reported by the U.S. Food and Drug Administration, the Specialty Medicine Compounding Pharmacy recalled products that were distributed directly to hospitals and patients located in the state of Michigan between July 1, 2013 and Oct. 19, 2013.
The compounding pharmacy found undetermined particulate matter floating in a sterile product. The recall was made because this lot may have been administered to patients already in a Michigan hospital.
FDA suggested the following steps be taken if you are a hospital, veterinarian, health care providers and patients that has received ANY sterile product from this compound pharmacy:
- Immediately discontinue use
- Quarantine all sterile products
- Return the recalled products to Specialty Medicine Compounding Pharmacy
The Medical Drug and Device Attorneys at Zoll, Kranz & Borgess, LLC can be contacted for more information. The toll-free number is 888-841-9623.