Medistat RX Drug Recall Due to Possible Contamination

Medistat RX, LLC, a Foley, Alabama, compounding pharmacy business, issued a recall of all non-expired drug products produced for sterile use due to possible contamination. The recalled products were distributed nationwide between November 1, 2014, and September 3, 2015. These products were produced after a September 2014 FDA inspection of the Medistat RX facility in Alabama observed significant deficiencies that raise concerns about Medistat’s ability to assure the sterility of drug products that it produced (see list of 10 observations below). Medistat voluntarily ceased sterile compounding operations on September 1, 2015.

There have been reports of illnesses associated with Medistat RX products sold as sterile, according to the FDA. Our law firm handles personal injury and wrongful death claims involving compounded medications. Attorney Fred Pritzker can be reached at 1-888-377-8900 (toll free) or by submitting our free consultation form (click here).

10 Observations Listed in FDA Form 483

FDA inspected the Medistat facility at 110 E. Azalea Avenue, Foley, Alabama, in September 2014 and issued a Form FDA 483. The inspection dates were September 9, 10, 12 and 18, 2014 (file no. 3006014626). The following are the 10 “Observations” listed in the Form 483:

1. Aseptic processing areas are deficient regarding the system for monitoring environmental condistions, specifically: a) Certification of laminar flow hoods, buffer rooms and ante rooms are not conducted under dynamic conditions; b) You have no scientific rational or written specifications (air exchange rates, particle counts, pressure differential) for the classified rooms where sterile compounding continues; You also do not perform personnel and environmental monitoring each day sterile products are made.
2. Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
3. Drug products failing to meet established specifications are not rejected. Specifically, you did not take corrective action for two lots of Progesterone capsules that failed potency and were distributed.
4. Each batch of drug product purporting to be pyrogen-free is not laboratory tested to determine conformance to such requirements. Specifically, endotoxin testing is not conducted on each batch of injectable drug products made from non-sterile drug products. In addition, you do not perform any growth promotion testing of the agar and media you use for sterility analysis.
5. Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release.
6. There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Specifically, you have not validated your production process to demonstrate each batch of drug products meets the identity, strength, quality and purity it purports to be.
7. Written procedures describing the handling of complaints do not include provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications, a determination as to the need for an investigation of any unexplained discrepancy, and explaining the reasons for the failure of the batch or any of its components to meet specifications. Specifically, you do not fully investigate complaints to determine if the complaint extended to other batches of the same drug or product and other drug products that may have been associated with the use of the same components. In addition, complaint procedures are deficient in that they do not include provisions that allow for the review to determine if the complaints represent serious and unexpected adverse experiences which are required to be reported to FDA.
8. Written records are not made of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications. Specifically, you do not document and have a written procedure to investigate unexplained discrepancies.
9. Clothing of personnel engaged in the manufacturing, processing and packing of drug products is not appropriate for the duties they perform. Specifically, employees were observed to use non-sterile cloth face masks while producing sterile drug products.
10. Routine calibration of equipment is not performing according to a written program designed to assure proper performance. Specifically, you have not calibrated the incubator thermometers.

If drugs are not sterile, they can be contaminated with bacteria, fungi (mold) or parasites. These dangerous pathogens can lead to severe illness from infection—meningitis, kidney failure, pancreatitis, stroke, abscess—or wrongful death.

We are a national product safety law firm. Our infection cases can involve product liability and medical malpractice claims.