Drug Recalls

IBSA Pharma Issues Voluntary Nationwide Recall of Select Lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution Due to Subpotency

Date: 02/01/2023

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

IBSA Pharma has posted a 27-lot recall of Tirosint®-Sol Oral Solution.

About this recall:

IBSA Pharma is voluntarily recalling 27 lots of TIROSINT®-SOL (levothyroxine sodium) Oral Solution to the consumer level. This voluntary recall has been initiated because these lots may be subpotent. The company’s analyses show a slight decrease below 95.0% of its labeled amount in levothyroxine sodium (T4) for some lots. This recall does not apply to TIROSINT® (levothyroxine sodium) capsules.

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.

TIROSINT®-SOL oral solution is a clear, colorless to slightly yellow solution supplied in a 1 mL white, non-transparent, unit-dose ampule. The dosage strength is identified on the box and the pouch and is associated with a distinct color. Each ampule bears a colored label with the dosage strength and the product name (TIROSINT®-SOL). For full prescribing information, visit www.TirosintSOL.comExternal Link Disclaimer.

What this means to you:

Patients being treated for hypothyroidism (underactive thyroid), who receive subpotent TIROSINT®-SOL, may experience signs and symptoms of hypothyroidism (underactive thyroid) which may include, fatigue, increased sensitivity to cold, constipation, dry skin, puffy face, hair loss, slow heart rate, depression, swelling of the thyroid gland and/or unexplained weight gain or difficulty losing weight. Over- or under-treatment with TIROSINT® SOL may have negative effects on growth and development, cardiovascular function, bone metabolism, reproductive function, cognitive function, emotional state, gastrointestinal function, and glucose and lipid metabolism. Any patients including those who might be pregnant, newborn infants, or elderly patients, should contact their physician or healthcare provider if they have

experienced any problems that may be related to taking or using this drug product. To date, IBSA Pharma has not received any reports of adverse events that have been determined to be related to this voluntary recall.

TIROSINT®-SOL is indicated for:

• Hypothyroidism – As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism.

• Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression – As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer.

IBSA Pharma is proactively notifying its wholesalers, retailers, and healthcare providers to discontinue distribution of the product being recalled and is arranging for the return of all recalled products. Patients who are currently taking TIROSINT®-SOL should not discontinue use without contacting their healthcare provider for further guidance and/or replacement prescription.

Consumers and healthcare providers with questions regarding this recall can contact IBSA Pharma by phone number at 1-800-587-3513 Monday through Friday between the hours of 9:00 am to 7:00 pm (EST), or by e-mail at medinfo@ibsapharma.com. 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 the 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.

Apotex Corp. Issues Voluntary Nationwide Recall of Brimonidine Tartrate Ophthalmic Solution, 0.15% Due to Cracks that Have Developed in Some of the Units Caps of the Bottles
Date: 03/02/2023

At Magellan Rx Management, we want to help you get the best possible care. We have created a site to share drug recall information.

Apotex Corp. has posted a lot recall of Brimonidine Tartrate Ophthalmic Solution.

About this recall:
Apotex Corp. is initiating a voluntary recall at the Consumer level for 6 lots of Brimonidine Tartrate Ophthalmic
Solution, 0.15% . This recall is being initiated out of an abundance of caution due to cracks that have developed
in some of the units caps of Brimonidine Tartrate Ophthalmic Solution bottles. There is a possibility the broken
cap may impact sterility and if so, adverse events may occur.

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.

Brimonidine Tartrate Ophthalmic Solution is an alpha-adrenergic receptor agonist indicated for the reduction of
elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension.

What this means to you:
Apotex Corp. is notifying all impacted direct accounts (Wholesalers, Distributors, Warehousing Chains, Mail Order
Pharmacy and Long-Term Care Pharmacy) of this voluntary recall via email and mail (FedEx Standard Overnight)
and is arranging for return of all recalled product.

Patients who have received the identified lots or have questions regarding this recall should contact their
pharmacy. They should immediately contact their health care provider for medical advice and return the identified
lots to Inmar Rx Solutions by contacting at the phone number provided in this press release.

Wholesalers, Distributors, Warehousing Chains, Mail Order Pharmacy and Long-Term Care Pharmacy should
return the recalled product to the place of purchase. Anyone with an existing inventory of the recalled product should quarantine the recalled lots immediately. Customers who purchased the impacted product directly from
Apotex Corp. can call Inmar Rx Solutions at 1-855-275-1273 (9:00am – 5:00pm, EST Monday thru Friday), to
arrange for their return. Consumers with the impacted units of Brimonidine Tartrate Ophthalmic Solution, 0.15%, can contact Inmar RxSolutions at 1-855-275-1273, to receive a recall/return packet including the Recall Stock Response Form (or you may obtain this form from clsnetlink.com External Link Disclaimer).

Consumers with questions regarding this recall can contact Apotex Corp. by phone at 1-800-706-5575 (8:30am –
5:00pm, EST Monday thru Friday) or email address UScustomerservice@Apotex.com. Consumers should contact
their physician or health care 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 the 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.