Recall: Pharm D Solutions Sterile Compounded Drugs
On 2018-09-10, the FDA announced that Pharm D Solutions is conducting a recall on Sterile Compounded Drugs due to a possible lack of sterility. The recalled products were sold under the brand name(s) Pharm D Solutions during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 2 drugs recalls due to potential lack of sterility, including compounded drug products, various homeopathic products and more. Additionally, there have been 29 drug and medical device recalls due to other health hazards as well as 70 food recalls.
Company Contact Information:
Name: Pharm D Solutions
Do you work for a company involved with this recall? Contact us to learn how you can control data, information and ads shown on this page.
Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Sterile Compounded Drugs
Brand Name(s): Pharm D Solutions
Reason for Recall: Lack of Sterility Assurance
Official Recall Date: 2018-09-10
Additional information provided by the FDA.gov:
For Immediate Release
September 10, 2018
Luis R DeLeon
Pharm D Solutions, LLC is voluntarily recalling all sterile compounded drug products within expiry to the clinic, physician or consumer level. These drug products are being voluntarily recalled due to concerns that practices at the pharmacy have the potential to pose a risk of contamination to products that are intended to be sterile. These concerns arose following a routine inspection of the pharmacy by FDA.
Administration of a non-sterile product that is intended to be sterile by subcutaneous, intramuscular, intravenous or ocular routes of administration may result in serious injury or death. The pharmacy has not received any reports of patient complaints or adverse events related to this recall. To date, Pharm D Solutions, LLC is not aware of any adverse events related to this recall. Nor is there any indication that the compounded sterile drug products being recalled are actually contaminated. No medications or any component thereof have been shown to be non-sterile. This voluntary recall is being conducted out of an abundance of caution and to promote patient safety, which is the pharmacy's highest priority.
The recall encompasses all compounded sterile drug products, within expiry, that were dispensed within the last twelve months. The sterile drug products subject to this recall were distributed nationwide and directly to customers and/or medical facilities. The recall does not affect the pharmacy's non-sterile compounded products or retail pharmacy operations.
The pharmacy has notified potentially affected customers of the voluntary recall via U.S. Mail and direct outreach. Customers who have received sterile compounded products subject to the voluntary recall should stop using and return the product to the pharmacy for a full refund.
Consumers with questions regarding this recall can contact Pharm D Solutions, LLC by calling Luis R DeLeon or Carlos DeLeon at 713-790-1693, Monday through Friday between 9:00 a.m. and 5:00 p.m., CST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Complete and submit the report Online: http://www.fda.gov/medwatch/report.htm Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
More information may be available at FDA.gov
Latest Safety Recalls
Select image for details, including additional styles.
Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.