Listed below are the drug, biologics and medical device recalls that may impact your ASC. Although ASCA makes every attempt to ensure this information is as complete and current as possible, ASCA cannot guarantee this as an exhaustive list of every recall that may impact your business. For the most up-to-date information on drug, biologics and medical device recalls, please visit the FDA website.
Sterile Drug Products from Vital Rx, dba Atlantic Pharmacy and Compounding: FDA Alert - Lack of Sterility Assurance
August 10, 2017
FDA is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed nationwide by Vital Rx Inc., dba Atlantic Pharmacy and Compounding, Pompano Beach, Florida, due to lack of sterility assurance. During FDA’s recent inspection of Atlantic Pharmacy, investigators observed insanitary conditions, including poor sterile production practices, which raise concerns about Atlantic Pharmacy’s ability to assure the sterility of the drug products it produces. Administration of a non-sterile product intended to be sterile may result in serious and potentially life threatening infections or death.
ICU Medical Issues Voluntary Recall of 0.9% Sodium Chloride Injection
July 31, 2017
ICU Medical, Inc. is voluntarily recalling one lot of 0.9% sodium chloride injection, USP, 1000 mL to the hospital/user level due to a confirmed customer complaint of particulate matter identified as stainless steel within a single flexible container. Injection of particulate matter could potentially lead to limited adverse events such as allergic reactions, local irritation and inflammation in organs or tissues, or other serious adverse health consequences.
Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance
June 22, 2017
Advanced Pharma, Inc., d/b/a Avella of Houston, is conducting a limited, voluntary recall due to Hospira Inc.’s June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by Advanced Pharma were repackaged and/or compounded at its Houston, Texas facility using certain Hospira products. The recalled products are specific lots of Potassium Phosphate and Succinylcholine Chloride. This is a secondary recall based on a Hospira's recent recall.
Hospira Issues Voluntary Recall for Sodium Bicarbonate, Other Products Over Microbial Growth
June 19, 2017
Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials; 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials; 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials; and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Voluntary Recall of Vancomycin Hydrochloride for Injection, USP by Hospira
January 25, 2017
Hospira, Inc. is voluntarily recalling one lot of Vancomycin Hydrochloride for Injection, USP (NDC: 0409-6510-01, Lot 591053A, Expiry Date 1NOV2017), to the hospital/retail level due to a confirmed customer report for the presence of particulate matter within a single vial. The product is packaged in a carton containing 1x100 mL vial. The lot was distributed from August 2016 through September 2016 in the United States. If particulate is administered to a patient, it may result in local swelling, irritation of blood vessels or tissue, blockage of blood vessels and/or low-level allergic response to the particulate. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the physician to visually inspect the product for particulate matter and discoloration prior to administration.
Recall of System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics for Reprocessing Duodenoscopes
August 18, 2016
The FDA is notifying health care facilities of Custom Ultrasonics' May 6, 2016 urgent medical device recall and advising users to stop using its System 83 Plus AERs for reprocessing of duodenoscopes. Based on the Agency’s February 2016 Safety Communication, at this time, facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. In addition, FDA is revising its February 2016 Safety Communication to communicate that Custom Ultrasonics’ System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
Recall of Sterile Drug Products from Medaus Pharmacy
April 4, 2016
The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients not to use unexpired drug products that are intended to be sterile that were produced by Medaus Pharmacy in Birmingham, Alabama, due to lack of sterility assurance. Medaus’ products were distributed nationwide and internationally.
Recall of Compounded Products by Reliable Drug Pharmacy
March 28, 2016
Reliable Drug Pharmacy is recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. All unexpired lots are subject to the recall. All recalled products were distributed to patients and veterinarians within California. A few products were shipped to Hawaii, New Mexico, and Michigan. The recall was issued after a series of onsite inspections by the FDA.
Recall of Human and Animal Sterile Drug Products from I.V. Specialty
March 9, 2016
The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty Ltd., Austin, Texas, due to lack of sterility assurance. On March 7, 2016, FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty.
Recall of Sterile Products from Abbott's Compounding Pharmacy
January 16, 2016
Abbott's Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments.
All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California. All recalled products have a label that includes the Abbott's Compounding Pharmacy name and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date. This recall impacts all sterile products distributed between 01/01/2015 and 01/14/2016.
New Reprocessing Instructions Validated for Olympus Duodenoscope Model TJF-Q180V
January 15, 2016
The FDA cleared the TJF-Q180V duodenoscope 510(k) with design modifications to the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.