New eye drop product recalled over risk of possible infection that 'could result in blindness'

The Food and Drug Administration (FDA) is recalling two more eye drop products since there was an emergency recall back in February. The two companies, Phamedica and Apotex, have issued voluntary recalls for some of their eye drops due to sterility issues which could mean a potential risk of infection or even blindness. Both companies are advising customers to stop using the products immediately and return it to the place of purchase

The recall of these products follows an emergency recall of eye drops from Global Pharma Healthcare earlier in the year due to possible contamination. The Artificial Tears Lubricant Eye Drops product, was linked to 'a cluster of bacterial infections across multiple states' in the US, as per Health Digest.

Apotex

Apotex Corp. is initiating a voluntary recall at the consumer level for six lots of Brimonidine Tartrate Ophthalmic Solution, 0.15% as specified below.

• Pack size - 5ml, NDC# 60505-0564-1, UPC Code on Carton - 360505056415, UPC Code on Bottle - (01)0(03) 60505056415, with lot# TJ9848 & TJ9849 with expiry date 02/2024
• Pack size - 5ml, NDC# 60505-0564-1, UPC Code on Carton - 360505056415, UPC Code on Bottle - (01)0(03) 60505056415, with lot# TK0258 & TK5341 with expiry date 04/2024
• Pack size - 10ml, NDC# 60505-0564-2, UPC Code on Carton - 360505056422, UPC Code on Bottle - (01)0(03) 60505056422, with lot# TK0261 with expiry date 04/2024
• Pack size - 15ml, NDC# 60505-0564-3, UPC Code on Carton - 360505056439, UPC Code on Bottle - (01)0(03) 60505056439, with lot# TK0262 with expiry date 04/2024

The company states that the recall is being initiated due to, as per FDA:

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, the possibility of adverse events.

Patients who have received these products or have any further questions should contact their pharmacy and return the items. Consumers can also contact Apotex Corp. by phone at 1-800-706-5575 (8:30am – 5:00pm, EST Monday thru Friday) or UScustomerservice@Apotex.com.

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Pharmedica

Pharmedica, which sells under the Purely Soothing brand of eye drops, is recalling two batches of its 15% MSM eye drops as the product may not be sterile. Pharmedica say that they haven’t received complaints from customers about the product but they are advising customers to stop using the products and return them to the place of purchase.

The eye drops that are being recalled are used as an anti-inflammatory for relieving symptoms of ocular irritation and swelling and come in white, cylindrical HDPE bottles.

• 15% MSM Drops - Comfortable and Soothing (lot#: 2203PS01, 1 oz, UPC 7 31034 91379 9; and lot#: 1808051, ½ oz, UPC 7 31034 91382 9) and have eye dropper caps and white lids.

FDA issued a risk statement for this specific eye drop product, stating:

Use of contaminated eye drops can result in the risk of eye infections that could result in blindness.

Consumers with any questions regarding this recall can contact Pharmedica USA LLC by phone at +1 (623) 698 - 1752 or osm@pharmedicausa.com Monday to Friday between the hours of 8:00 AM MST (AZ) and 5:00 PM MST (AZ), as per the FDA.

Consumers are advised to contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.

Read more: Warning issued over tap water after woman catches rare and potentially fatal infection

Sources used:

- FDA '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'

- FDA 'Pharmedica USA LLC Issues Voluntary Worldwide Recall of Purely Soothing 15% MSM Drops Due to Non-Sterility'

- Health Digest 'FDA Recalls Two More Eye Drop Products After Emergency Recall In February'