Drug Recalls

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.