Ranier’s Rx Labs Compounded Drug Recall [US]

US FlagUS/Silver Spring: Ranier’s Rx Labs Compounded Drug Recall [US]Ranier’s Rx Laboratory, a Jeannette, Pennsylvania establishment, recalls all Sterile Compounded Drug products within expiry to the hospital and consumer level due to suspected non-sterility and possibly contamination with consequential risk of patient hospitalization, significant morbidity, organ damage or fatal outcomes, all serious health and safety hazards.

FDA: http://ht.ly/tIzh30lbJPg

Direct link: https://www.fda.gov/Safety/Recalls/ucm615054.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Compounded Drug products are subject to this recall:

  • All Sterile Compounded Drug products prepared and/or sold by Ranier’s Rx Laboratory within expiry to the hospital or consumer level

==> Due to the nature of these drug compounds, no barcodes, UPCs, DINs, item numbers or other identification numbers were listed with this recall notification.

According to the FDA, these Compounded Drug products are being recalled due to concerns that practices at Ranier’s Rx Laboratory 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 a site-specific or systemic infection which in turn may result in hospitalization, significant morbidity, organ damage, or a fatal outcome. The pharmacy has not received any reports of patient complaints or adverse events related to this recall. To date, FDA is not aware of any adverse events associated with the use of compounded drug products from the pharmacy.

The recall encompasses all Sterile Compounded Drug products within expiry, that were dispensed between January 17, 2018, and July 10, 2018 by Ranier’s Rx Laboratory. The Sterile Compounded Drug products subject to this recall were distributed only within the State of Pennsylvania and directly to customers and/or medical facilities.

If you have purchased or acquired any Sterile Compounded Drug products between the time frames discussed from Ranier’s Rx Laboratory, either directly or indirectly, please return them to the place of purchase for a full refund.

If you have any questions concerning this recall, please contact Ranier’s Rx Laboratory by calling Jennifer Henry at 1-724-527-2752, Monday through Friday between 9:00 AM and 5:00 PM, Eastern Standard Time. If you feel ill or otherwise unwell, please contact your physician, clinic or other qualified healthcare provider on an urgent basis.

==> Never depend on your senses of sight, smell, taste or touch to confirm drug poisoning, adulteration or contamination. If in doubt about the safety of any drug, return it to your retailer for refund and speak with your physician concerning your continued drug treatment plan.

==> To see other recalls and notifications caused by suspected contaminated, adulterated or mislabeled Compounded Drug products, please search for “compounded” or more generically, “drug” using the Search Box at the top of this page.

==> To see other recalls and notifications for products manufactured, marketed and/or sold by Ranier’s Rx Laboratory please search for “Ranier,” using the Search Box at the top of this page.


More information about this recall:
Recalls Direct RIN: 10456-2018
Want to read more about this recall?
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General information:
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==> http://www.fda.gov/Safety/Recalls/ArchiveRecalls/default.htm

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