StemGenex Biologic Laboratories LLC Warned by FDA for Unapproved Marketing & Manufacturing Violations

StemGenex Biologic Laboratories LLC Warned by FDA for Unapproved Marketing & Manufacturing Violations

The FDA has issued a warning to StemGenex Biologic Laboratories LLC (StemGenex) for marketing a purported stem cell product without FDA approval and for significant manufacturing violations, including some that could lead to microbial contamination in patients.

Specifically, FDA investigator observed unvalidated manufacturing processes, an uncontrolled environment, a lack of control over the components used in production, and a lack of sufficient and validated product testing in an inspection.

The illegal stromal vascular fraction (SVF), which is a cellular product derived from body fat, is being used to treat conditions like Alzheimer’s disease, Crohn’s disease, Type I and Type II diabetes, fibromyalgia, spinal cord injury, chronic obstructive pulmonary disease, multiple sclerosis, muscular dystrophy, Parkinson’s disease, peripheral neuropathy, and rheumatoid arthritis.

Lacking licenses include a valid biologics license and an investigational new drug application (IND).

For more information on this warning, read the FDA’s statement.

Caution with Use of Implanted Pumps Encouraged by FDA

The FDA has issued a warning to patients, healthcare providers, compounders, and caregivers to use implanted pumps with caution. The pumps are often used to deliver prescription medicines and fluids within the body via the intrathecal space (spinal fluid).

The warnings specify which medications can be administered through the pumps. The only approved medications to be administered through the pumps are morphine sulfate (INFUMORPH), a preservative free, injectable solution; and preservative free ziconotide sterile solution (PRIALT).

Medications not FDA-approved for administration through the pumps include hydromorphone, bupivacaine, fentanyl, and clonidine; any mixture of 2 or more different kinds of medicines; and any compounded medicine.

Use of inappropriate medication in the pumps can result in pump failures, which can result in dosing errors.

For more information on this warning, read the FDA’s statement.

Millennium Nuclear Medicine Systems Recalled Due to Risk of Malfunctions

Due to an incident in which the top detector detached and fell onto the detector below it, GE Healthcare is recalling Millennium Nuclear Medicine Systems.

A malfunctioning primary motion stopper and a missing mechanical stopper were determined as the causes of the incident. The products’ malfunctions restrain the detectors from going beyond their limits during normal operation.

Patients at risk include, “Hospitals and healthcare professionals using a Millennium MG, Millennium MC, or Millennium MYOSIGHT Nuclear Medicine System for patient imaging procedures; patients undergoing imaging procedures using a Millennium MG, Millennium MC, or Millennium MYOSIGHT Nuclear Medicine System; field Service Engineers servicing a Millennium MG, Millennium MC, or Millennium MYOSIGHT Nuclear Medicine System.”

To date, no patient injuries have been reported.

For more information on this recall, read the FDA’s statement.

Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models) Recalled Due to Risk of Malfunction

Due to the risk of malfunction, Oscor Inc. is recalling certain lots TB Unshrouded Bipolar Pacing Leads (Recall No. 1035166- 09/07/2018-01-R).

The models are intravenously used to temporarily pace and sense the heart in conjunction with a compatible external pulse generator.

Since the connector cap housing could slide, potentially exposing the connection wire, Oscor is issuing the recall.

A total of 4 serious injuries attributed to the above connector cap malfunction were reported to Oscor in the last 6 years. However, no deaths have been reported.

For more information on this recall, read the FDA’s statement.

For FDA recalls and safety updates regarding food products, visit Contagion®’s recall list.