FDA announces voluntary recall of products from compounding pharmacy in Michigan
The U.S. Food and Drug Administration announced a voluntary recall of certain human and veterinary products from a compounding pharmacy in Michigan.
The recall applies to some products produced and distributed for sterile use by Specialty Medicine Compounding Pharmacy in South Lyon, Mich. The list of products includes some agents used in eye care, according to an FDA news release.
The pharmacy initiated the recall after unidentified particulate matter was found floating in a sterile product from the same lot as products that may have been administered at a hospital in Michigan.
The recalled products were distributed to hospitals and patients in Michigan between July 1, 2013, and Oct. 19, 2013. No products were distributed outside the state of Michigan, the release said.
“At this time, the FDA recommends that any sterile product produced by Specialty Medicine Compounding Pharmacy should not be used or administered to patients or animals,” the release said. “Hospitals, health care providers, veterinarians and patients who have received any sterile product produced by Specialty Medicine Compounding Pharmacy should immediately discontinue use, quarantine all sterile products and return the recalled products to Specialty Medicine Compounding Pharmacy.”
No adverse events had been reported at the time of the recall announcement. The FDA is working with the Centers for Disease Control and Prevention and Michigan state officials to ascertain the extent of contamination, the release said.
Adverse reactions from any of the recalled products may be reported online to the FDA’s MedWatch Adverse Event Reporting program at https://www.accessdata.fda.gov/scripts/medwatch/ or by downloading and completing a form and faxing it to the FDA at 800-332-0178.
For more details about the recall, contact Specialty Medicine Compounding Pharmacy at 248-446-2643.