Drug Recalls

Avkare is voluntarily recalling lot # AW0221A (expiry 08/2025) of Atovaquone Oral Suspension, USP 750 mg/5 mL

About this recall:

Avkare is voluntarily recalling lot # AW0221A (expiry 08/2025) of Atovaquone Oral Suspension, USP 750 mg/5 mL (NDC # 50268-086-12) to the consumer/user level due to the potential for Bacillus cereus contamination found during stability testing at a third-party lab. In immunocompromised patients, the potential exists that microbial contamination could lead to disseminated, life-threatening infections such as endocarditis or necrotizing soft tissue infections. Classification: The United States (US) Food and Drug Administration (FDA) has classified this as a CLASS 1 LOT RECALL. FDA Link: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/avkare-llc-issues-voluntary-nationwide-recall-atovaquone-oral-suspension-usp-750-mg5-ml-due

What this means to you:

You must complete your client-specific requirements by the MRx action date listed in the table above. Typically, this requires notification to your clients of the event and, as appropriate, any claims information found. Some accounts are contractually required to notify members and prescribers. Any NCQA client (our Health Plan business) requires both parties be notified. Magellan Rx Management, LLC is accredited by NCQA in Utilization Management. Therefore, Magellan falls under the same requirements. Lot recalls are an exception to the notification process under NCQA standards; however, contract requirements may supersede this exception.

Client Documents
The attached memo is being provided for your use and will be shared with your clients via Customer Relationship Management (CRM).

Claims
There were NO claims for accounts available to us in the Pharmacy Data Warehouse (PDW). This search did NOT cover any claims for SS&C (formerly DST) accounts that are not in the PDW. Account Teams will need to run their own report to check for claims for these plans.

Other Information
To access all information related to this recall, please use the link below to access the FDA Alerts SharePoint Online Site and take the following steps.

1. Select the “2024 Actioned Alerts” folder.
2. Select the applicable folder based on recall type.
3. Open the folder of the recall (all recall folders are titled with the drug name and manufacturer).
4. If a file will not open, select the individual radio button to the left of the file name and select “Download” on the toolbar at the top.

Important Links

• FDA Alerts SharePoint Site: https://ptportal.sharepoint.com/sites/MRxClinicalDI/FDA_Alerts/Forms/AllItems.aspx?viewpath=%2Fsites%2FMRxClinicalDI%2FFDA%5FAlerts%2FForms%2FAllItems%2Easpx
• Quality Improvement Procedure Library: https://ptportal.sharepoint.com/sites/MRxProcedureLib/SitePages/Home.aspx
• Drug Recalls page: https://www1.magellanrx.com/drug-recalls/

Other Resources
If you have any questions about this recall, the claim reports, or the recall process, please contact the Quality Team at MRxQualityDepartment@primetherapeutics.com.

Recall Classifications
Each FDA recall, warning, or alert is evaluated independently to determine the scope, classification, and timeframe for response. The FDA defines recalls as follows:

• Class 1: A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
• Class 2: A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Market Withdrawal: Occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems would be a market withdrawal.

About this recall:

Amneal is voluntarily recalling 4 lots of Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/5 mL packaged in 80 mL, 150 mL, or 300 mL pack sizes, to the consumer level. Some bottles may have been overfilled which can result in an over potent dosing regimen. The recommended maximum daily dose is up to 2 gm/day, and patients prescribed a dosing regimen of 500 mg/10 mL would exceed this daily allowance, which may be harmful to patients with kidney insufficiency. The following NDCs and lot numbers are being recalled.

Vancomycin hydrochloride for oral solution is administered for treatment of inflammation of the intestines caused by Staphylococcus aureus (including methicillin-resistant strains) and antibiotic-associated pseudomembranous colitis (inflammation of the inner lining of the large intestine) caused by Clostridioides difficile (C. difficile).

What this means to you:

Adult patients who are prescribed the maximum daily dose of up to 2 grams per day of vancomycin hydrochloride for oral solution, 250 mg/5 mL, may receive up to 4 grams of oral vancomycin per day due to the overfilled bottle. Some patients with inflammatory disorders of the intestines also may have substantial absorption of the vancomycin. These patients may be at risk for adverse effects associated with higher doses of vancomycin. Worsening kidney function could be associated with electrolyte abnormalities such as high potassium leading to cardiac arrest.

Consumers who have Vancomycin Hydrochloride for Oral Solution, USP, 250 mg/mL should examine the bottle, stop using the product if the NDC and lot number is listed on the recall, and contact Amneal via telephone or email for recall information and for product return instructions. Consumers may call Amneal at 1-833-582-0812 Monday through Friday, 8:00 am to 5:00 pm, EST, or email Vancomycin_Recall@amneal.com for further information and instructions on the product return. Consumers should contact their 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 United States (US) Food and Drug Administration.

For more information regarding this FDA Recall Notification, please refer to the FDA website:

https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceuticals-llc-issues-nationwide-voluntary-recall-vancomycin-hydrochloride-oral-solution

FDA contact information for reporting adverse events/quality complaints can be reached online at https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home or by calling the FDA at 1-888-INFO-FDA (1-888-463-6332) and then selecting prompt #2.

Par Issues Voluntary Nationwide Recall of One Lot of Treprostinil Injection Due to Potential for Silicone Particulates

About this recall:
Par is voluntarily recalling one lot of Treprostinil injection 20 mg/20 mL (1 mg/mL) to the consumer level. The product is being recalled due to the potential for silicone particulates in the solution. Treprostinil injection 20 mg/20 mL is supplied in 20 mL multidose vials as sterile solutions in water for injection, individually packaged in cartons under NDC #42023-206-01. Only lot #57014 (expiration date 04/2024) is impacted by this recall. This lot was distributed nationwide to wholesalers and hospitals from June 16, 2022 through October 17, 2022.

Treprostinil injection can be given under the skin or as an intravenous (IV) infusion. The product is a prostacyclin vasodilator FDA-approved for the treatment of pulmonary arterial hypertension (PAH) to decrease symptoms associated with exercise as well as for patients who require transition from epoprostenol to reduce the rate of clinical deterioration.

What this means to you:
Administration of an injectable product that contains particulates may result in local irritation or swelling due to the foreign material. If the particulate reaches the blood vessels, it can travel to various organs and block blood flow in the heart, lungs, or brain which can lead to stroke and could result in death. Consumers should contact their healthcare provider if they have experienced any problems that may be related to using this drug product.

For information regarding the recall process, call Inmar at 1-855-410-3565 Monday through Friday between the hours of 9 am and 5 pm EST. For medical product information or to report a product complaint or adverse event please call 1-800-828-9393.

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 United States (US) Food and Drug Administration.

Brassica Issues Voluntary Nationwide Recall of Multiple Eye Ointment Products Multiple Products Due to Potential Lack of Sterility

About this recall:

Brassica is voluntarily recalling certain lots of the following over the counter (OTC) eye ointment products with
expiration dates ranging from February 2024 to September 2025: Equate™ Lubricant Eye Ointment (NDC 79903-
026-35), Equate Stye™ Lubricant Eye Ointment (NDC 79903-028-35), CVS Health® Lubricant Eye Ointment (NDC
76168-707-35), and Lubricant PM Ointment (NDC 71406-124-35). The lots are being recalled due to lack of sterility
assurance that was found during an inspection conducted by the United States (US) Food and Drug Administration
(FDA).

For lot recalls, the lot/batch information and expiration date for the recalled product can be viewed by clicking on
the link to the FDA Recall Notification found below.

These eye ointment products are for the temporary relief of burning, irritation, and discomfort due to dryness of
the eye or exposure to wind and sun. These products may also be used as a protectant against further irritation.

What this means to you:

For those patients who use these recalled products, there is a potential risk of eye infections or similar problems. These products are intended to be sterile. Eye products have a higher risk of harm because
drugs applied to the eyes bypass some of the body’s natural defenses.
Consumers should stop using the recalled eye ointment and may return the recalled products to the place of purchase.

Consumers with questions regarding this recall can contact Brassica at 1-833-225-9564 or info@brassicapharma.com. Consumers should contact their 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 US FDA.

Azurity Issues Voluntary Nationwide Recall of Zenzedi® (dextroamphetamine sulfate) Tablets 30 mg Due to a Mislabeled Package

About this recall:

Azurity is voluntarily recalling 1 lot of Zenzedi® (dextroamphetamine sulfate tablets) 30 mg to the consumer level. The product is being recalled due to a report from a pharmacist who opened a bottle of Zenzedi® 30 mg tablets and found tablets of carbinoxamine maleate, an antihistamine drug. The recalled drug is NDC # 24338-856-03 with lot # F230169A and expiration date June 2025.

Zenzedi® is a prescription medicine FDA-approved for (1) the treatment of narcolepsy and (2) as a treatment for attention deficit hyperactivity disorder (ADHD). The press release linked on the following page provides a description of the appearance of Zenzedi 30 mg tablets and a description of the appearance of carbinoxamine maleate tablets.

What this means to you:

Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in impairment and an increased risk of accidents or injury. Patients who consume carbinoxamine could experience side effects such as drowsiness, sleepiness, central nervous system depression, increased eye pressure, enlarged prostate leading to urinary obstruction, and thyroid disorders. For patients with ADHD and narcolepsy, the potential exists for accidents or injuries to occur due to the sedating effects of carbinoxamine. These accidents or injuries could be serious and result in disability or death in severe cases, especially if individuals engage in activities requiring significant focus and alertness, such as driving or operating heavy machinery. To date, Azurity has not received any reports of serious adverse events related to this recall.

Consumers that have product which is being recalled should stop using and return to the place of purchase. Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking this recalled drug. An adverse event may also be reported to Azurity via email at aereports@azurity.com.

For more information regarding this recall, please refer to the following telephone numbers:

• For information on the recall process, call Inmar at 877-804-2069 (Monday to Friday, 9 am to 5 pm EST).
• For medical information or to report a side effect, call 800-461-7449 (Monday to Friday, 9 am to 5 pm EST).

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 United States (US) Food and Drug Administration.