News & Press: Patient Safety

5/14 - The Compounding Shop: FDA News Release - Lack of Sterility Assurance of Drug Products

Wednesday, May 8, 2013  
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UPDATE - The Compounding Shop: In Cooperation with FDA, The Compounding Shop, LLC Declares a Voluntary Recall of All Lots of Sterile Compounded Products Due to a Lack of Sterility Assurance Distributed Within Its Local Market Area.

The Compounding Shop, LLC is conducting a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired. The recall is being initiated due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.

In the event a sterile product is compromised patients are at risk for very serious infections. To date, The Compounding Shop has received no reports of injury or illness associated with the use of its sterile products. However, out of the abundance of caution and in the interest of the pharmacy's patients, The Compounding Shop has decided to voluntarily proceed with this recall process and to cease production of sterile products until further notice.

These products were supplied to the offices of licensed medical professionals and to patients by prescription within the pharmacy's local market area. The Compounding Shop is notifying its customers by fax, phone or email to return products to the pharmacy. Consumers or health care providers with questions regarding this recall may contact The Compounding Shop at 727-381-9799 or toll free 866- 792-6731 Monday through Friday, 10:00 a.m. to 6:00 p.m. or by email Be advised, this recall does not pertain to any non-sterile compounded medications produced by the pharmacy. Patients who have received any product by The Compounding Shop and have concerns should contact their healthcare provider.

 Source: Firm Press Release (Accessed: 5/13/2013)

ISSUE: The U.S. Food and Drug Administration is alerting health care providers, hospital supply managers, and pharmacists that the FDA’s preliminary findings of practices at The Compounding Shop of St. Petersburg, Fla., raise concerns about a lack of sterility assurance for sterile drugs produced at and distributed from this site. Therefore, these products should not be administered to patients. If a drug product marketed as sterile has microbial contamination, it potentially places patients at risk of serious infection.


The FDA has advised the firm that it is in the best interest of public health to take action to remove all sterile products from the market. The Compounding Shop has informed the FDA that it is recalling sterile products and is in the process of notifying customers.

BACKGROUND: The FDA is basing this warning on a recent inspection of The Compounding Shop. The investigators observed poor sterile production practices that raise concerns about a lack of sterility assurance of The Compounding Shop’s sterile drug products.

RECOMMENDATION: Health care providers and hospital staff should immediately check their medical supplies, quarantine any sterile products from The Compounding Shop, not administer them to patients, and await further instructions from the company regarding the recalled products. Patients who have received any product produced by The Compounding Shop and have concerns should contact their health care provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online:
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

Read the complete MedWatch Safety Alert, including a link to the News Release, HERE.

Source: U.S. Food and Drug Administration (FDA) (Accessed: 5/8/2013)

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