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Wednesday, March 16, 2022
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Olympia Pharmacy Issues Voluntary Nationwide Recall of Seven Compounded Products Due to Being Out-of-Specification
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
- Products are out of specification
- Company Name:
- Olympia Pharmacy
- Brand Name:
- Olympia Pharmaceuticals
- Product Description:
- Compounded Injectables
Company Announcement
Olympia Pharmacy is voluntarily recalling 11 specific lots of Trimix Formulas F-9, T-105, SB-4, Sermorelin, Sincalide, Hydroxocobalamin, and NAD, compounded injectables to the consumer level. These compounded products were found to be out-of-specification.
Risk Statement: Administration of subpotent Hydroxocobalamin in infants, pregnant/breastfeeding women, and elderly populations are at risk for vitamin B12 deficiency and there is a reasonable probability they could experience adverse events including muscle weakness, neurological peripheral neuropathic numbness or pain, vision loss, and psychiatric disorders (depression, memory loss). Additionally, injectable compounded products, found to contain more or less drug product than the labeled strength or which reconstitute at a different rate than intended, may result in either too much or too little medication being administered. This could result in lower-than-expected effectiveness of the drug or unintended adverse side effects.
Olympia Pharmacy has not received any reports or concerns from patients relating to the safety of the recalled sterile compounded products, and no patients have reported any adverse events attributed to any of the recalled sterile compounded products.
The compounded products being recalled are typically prescribed by medical professionals for age management, erectile dysfunction, vitamin deficiencies, and for diagnostic imaging of the gallbladder. The affected lots include the following lot numbers and expiration dates listed below. The product can be identified by reading the lot number in the black strike zone of the label and was distributed to patients and health clinics.
| Drug | Vial Size | Lot | Best Use Date |
|---|---|---|---|
| NAD | 500mg vial | C41008 | 3/8/22 |
| NAD | 500mg vial | D24005 | 4/5/22 |
| Sincalide | 5 mcg vial | D24001 | 4/1/22 |
| Trimix Formula F9 | 10 ml vial | D41C19 | 4/19/22 |
| Sermorelin Acetate 9 mg | 9 mg vial | D44026 | 4/26/22 |
| Sermorelin Acetate 9 mg | 9 mg vial | F42104 | 6/4/22 |
| Trimix T-105, | 5 ml vial | E41F10 | 5/10/22 |
| Trimix T-105, | 10 ml vial | E41G10 | 5/10/22 |
| Trimix SB-4 | 5 ml vial | E41C18 | 5/18/22 |
| Trimix SB-4 | 10 ml vial | E41D18 | 5/18/22 |
| Hydroxocobalamin 1mg/ml | 30 ml vial | E47025 | 5/21/22 |
Olympia Pharmacy is notifying its customers by mail and is arranging for return and replacement of all recalled compounded products. Patients and health clinics that have any of the listed compounded products which are being recalled should stop using and return to Olympia Pharmacy.
Consumers with questions regarding this recall can contact Olympia Pharmacy by phone at 407-250-4000 or e-mail clientservices@olympiapharmacy.com Monday through Friday from 9 am to 6 pm Eastern Standard Time.
Adverse reactions or quality problems experienced with the use of this product 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
- Regular Mail or Fax: 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Consumers:
- Recall Coordinator
- 407-250-4000
- clientservices@olympiapharmacy.com
"Kent Courtheyn, 38, of Kent, Ohio, owner and operator of two marketing companies involved in the sales and marketing of compounded medications – IntegriMed Solutions LLC (IntegriMed) and KA Compounding LLC (KA Compounding) – pleaded guilty by videoconference before U.S. District Judge Madeline Cox Arleo to an information charging him with conspiracy to defraud the United States by committing health care fraud and violating the anti-kickback statute."
Department of Justice
U.S. Attorney’s Office
District of New Jersey
FOR IMMEDIATE RELEASE
Monday, March 14, 2022
Ohio Man Admits Role in Multimillion-Dollar Scheme to Defraud Health Care Benefit Programs
NEWARK, N.J. – An Ohio man pleaded guilty today to his role in a large-scale, multilevel marketing scheme to defraud private and federally funded health care benefit programs, U.S. Attorney Philip R. Sellinger announced.
Kent Courtheyn, 38, of Kent, Ohio, owner and operator of two marketing companies involved in the sales and marketing of compounded medications – IntegriMed Solutions LLC (IntegriMed) and KA Compounding LLC (KA Compounding) – pleaded guilty by videoconference before U.S. District Judge Madeline Cox Arleo to an information charging him with conspiracy to defraud the United States by committing health care fraud and violating the anti-kickback statute.
According to documents filed in this case and statements made in court:
TRICARE is a health care entitlement program of the U.S. Department of Defense (DoD) Military Health System that provides coverage for DoD beneficiaries worldwide, including active duty service members, National Guard and Reserve members, retirees, their families, and survivors. Compounded medications are specialty medications prepared by a pharmacist to meet the specific medical needs of an individual patient. Although compounded drugs are not approved by the Food and Drug Administration (FDA), they are properly prescribed when a medical professional determines that an FDA-approved medication does not meet the health needs of a particular patient, such as when a patient is allergic to a dye or other ingredient or when a patient cannot consume a medication by traditional means.
From July 2014 through July 2016, Courtheyn, a former medical device sales representative, ran a large-scale scheme to defraud federally funded health care benefit programs, such as TRICARE, as well as privately funded health care benefit programs. Through IntegriMed and KA Compounding, Courtheyn recruited individuals to submit fraudulent claims for medically unnecessary compounded medications, such as pain creams, scar creams, wound creams, and metabolic vitamins, without regard to medical necessity. In total, Courtheyn defrauded health care benefit programs, including TRICARE, of at least $5.8 million.
Courtheyn faces a statutory maximum of five years in prison and a $250,000 fine, or twice the gross gain or loss from the offense, whichever is greatest. Sentencing is scheduled for July 20, 2022.
U.S. Attorney Sellinger credited special agents of the FBI, under the direction of Special Agent in Charge George M. Crouch Jr. in Newark; and the U.S. Department of Defense, Office of Inspector General, Defense Criminal Investigative Service, Northeast Field Office, under the direction of Special Agent in Charge Patrick J. Hegarty, with the ongoing investigation leading to today’s guilty plea.
The government is represented by Assistant U.S. Attorney Osmar J. Benvenuto, Deputy Chief of the Criminal Division in Newark.
Attachment(s):
Topic(s):
Health Care Fraud
Component(s):
Press Release Number:
22-092
Updated March 14, 2022
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Monday, March 14, 2022
Wednesday, March 9, 2022
Braun Medical Inc. Issues Voluntary Nationwide Recall of 0.9% Sodium Chloride for Injection USP 250ML in Excel Due to Fluid Leakage or Low Fill Volume
Summary
- Company Announcement Date:
- FDA Publish Date:
- Product Type:
- Drugs
- Reason for Announcement:
- Fluid leakage and low fill volume may cause a lack in sterility
- Company Name:
- B. Braun Medical Inc.
- Brand Name:
- B. Braun Medical Inc.
- Product Description:
- 0.9% Sodium Chloride for Injection USP 250ML in Excel
Company Announcement
B. Braun Medical Inc. (B. Braun) is voluntarily recalling five (5) lots of 0.9% Sodium Chloride for Injection USP 250ML in Excel within the United States to the hospital/user level. The voluntary recall has been initiated due to fluid leakage or low fill volume of the respective containers.
The biggest risk with a slow leak in any intravenous solution preparation is a break in sterility which poses a risk for the patient being exposed to a bacterial or fungal infection. There is a remote probability this could lead to bloodstream infection. B. Braun has not received any reports of adverse events related to this recall.
0.9% Sodium Chloride for Injection USP in Excel is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP in Excel is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells.
| Product Catalog Number: | Lot Number: | NDC: | Product Description: | Distribution Date Range: | Expiration Date: | Region Distributed: |
|---|---|---|---|---|---|---|
| L8002 | ||||||
| J1E086 | 0264-7800-20 | 0.9% NACL INJ USP 250ML | 15JUN2021 – 22JUL2021 | 31-May-23 | United States | |
| J1E204 | 0264-7800-20 | 0.9% NACL INJ USP 250ML | 17JUN2021 – 21JUL2021 | 31-May-23 | United States | |
| J1E213 | 0264-7800-20 | 0.9% NACL INJ USP 250ML | 02JUN2021 – 28JUN2021 | 31-May-23 | United States | |
| J1H137 | 0264-7800-20 | 0.9% NACL INJ USP 250ML | 14JUL2021 – 20OCT2021 | 30-Jun-23 | United States | |
| J1H138 | 0264-7800-20 | 0.9% NACL INJ USP 250ML | 14JUL2021 – 29OCT2021 | 30-Jun-23 | United States |
Product was distributed Nationwide within the United States to domestic distributors.
B. Braun is notifying its distributors and customers by an official recall notice sent via certified registered mail and is arranging for return of all recalled products. Facilities and distributors that have product which is being recalled should discontinue use immediately and contact the B. Braun Medical Inc. Customer Support Department at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST to arrange for product return.
Facilities with questions regarding this recall can contact B. Braun by phone at 800-227-2862 Monday through Friday, 8 a.m. – 6 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product 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
- Regular Mail or Fax: 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
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Company Contact Information
- Consumers:
- B. Braun
- 800-227-2862
- Media:
- Allison Longenhagen
- 484-523-9801
- allison.longenhagen@bbraunusa.com
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