Recall Information Center

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
UPDATED August 18, 2017
Vital Rx, Inc., dba Atlantic Pharmacy and Compounding, issued recall of all lots of all compounded injectable prescription medications to the consumer level.

August 10, 2017
The 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 the 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., dba 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 15, 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.

 

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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, the FDA is revising its February 2016 Safety Communication to communicate that Custom Ultrasonics’ System 83 Plus AERs remain in service for the reprocessing of endoscopes other than duodenoscopes.

Recall of Sterile Drug Products from Medaus Pharmacy
April 4, 2016
The US 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 Pharmacy's 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 on-site inspections by the FDA.

Recall of Human and Animal Sterile Drug Products from IV Specialty
March 9, 2016
The US 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, the FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all unexpired drug products intended to be sterile. The company has neither ceased sterile production nor initiated a recall. Therefore, the 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.

FUJIFILM Medical Systems, USA., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes
December 23, 2015
Fuji issued revised, validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. The FDA reviewed the revised reprocessing instructions and the validation data and determined that they meet the Agency’s expectations. We recommend that facilities using Fuji’s ED-530XT duodenoscope train staff on the new instructions and implement them as soon as possible.

Perseus A500 Anesthesia Workstation by Draeger: Class I Recall - Faulty Power Switch May Cause Device to Stop Working
December 23, 2015
Draeger is recalling the Perseus A500 anesthesia workstation because a faulty power switch may fail, causing the workstation to alarm and shut down unexpectedly. If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen. This could cause patients to suffer serious adverse health consequences, including injury or death. The recall includes all Draeger Perseus A500 anesthesia workstations manufactured from June 1, 2013, to September 30, 2015, with distribution dates of February 1, 2015, to September 30, 2015. See the FDA Recall Notice for a link to a list of affected serial numbers.

The company has received one report of this issue occurring, with no injuries and no deaths.

Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods
November 13, 2015
In accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics, the FDA ordered Custom Ultrasonics to recall all of its Automated Endoscope Reprocessors (AERs) from health care facilities due to the firm’s continued violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), applicable regulations, and the Consent Decree. FDA is recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.

Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance
October 21, 2015
Downing Labs, LLC is voluntarily recalling all lots of sterile products compounded and packaged by Downing Labs and that remain within expiry due to concerns over sterility assurance. The products were distributed nationwide and in the UK to patients and providers between April 20, 2015 and September 15, 2015. If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.

Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength
October 9, 2015
On October 9, 2015, Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”. The Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets. This error is not easily identifiable by the user or prescriber. If the product is taken at the maximum labeled dose, every four hours, five doses a day, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure. See the firm Press Release for further details.

Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance
September 24, 2015
US Compounding, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by USC and that remain within expiry due to FDA concern over a lack of sterility assurance. The sterile products were distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015 and September 9, 2015. If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk. 

Hospira Recalls One Lot of Preservative-Free Bupivacaine HCl Injection
April 27, 2014
Hospira issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose due to one confirmed customer complaint of iron oxide particulate in glass vials.

Select Lots of Baxter IV Solutions Recalled
April 10, 2015
Baxter International Inc. is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter.

Products Recalled from Prescription Center Pharmacy in Fayetteville, NC
April 3, 2015
FDA is joining the North Carolina Board of Pharmacy to urge health care professionals and patients not to use products made and distributed by the Prescription Center pharmacy, located at 915 Hay St., Fayetteville, North Carolina.

Hospira Issues a Voluntary Nationwide Recall of One Lot of Lactated Ringer's Irrigation Due to Mold Contamination
March 12, 2015
Anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. Customers should notify all users in their facility.

Hospira Announces Recall of 0.9 Percent Sodium Chloride Injection
March 6, 2015
Hospira announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV flex container to the user level due to one confirmed customer report of particulate in a single unit.

FDA Issues Endoscope Warning Following Superbug Outbreak
February 20, 2015
The FDA wants to raise awareness among health care professionals that the complex design of duodenoscopes may impede effective reprocessing.

Hospira Recalls Ketorolac Tromethamine Injection
February 11, 2015
Hospira announced a voluntary recall of ketorolac tromethamine injection, USP in the United States and Singapore due to potential particulate. The presence of particulate has been confirmed through a customer report of visible, floating particulate identified in glass fliptop vials.

Hospira Recalls 0.9 Percent Sodium Chloride Injection
January 27, 2015
Hospira, Inc. announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit.

FDA Warns Health Care Professionals Not to Inject Patients with Wallcur IV Solutions
January 5, 2015
The FDA is alerting health care professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients. There have been reports of serious adverse events associated with the use of certain of these products – i.e., Practi IV Solution Bags.