FDA Adds Two Eye Drops to Its Recall List Due to Supply Chain Issues

Last week, the FDA added two more eye drops to its recall list: Apotex Corp Brimonidine Tartrate Ophthalmic Solution (0.15%) and Pharmedica USA LLC Purely Soothing 15% MSM Drops. These recalls follow a recall on batches of artificial tears in early February 2023. Each manufacturer voluntarily issued recalls, which can be linked to supply chain issues.

On March 2, 2023, the FDA published a press release announcing the voluntary recall of Apotex Corp’s ophthalmic solution, one day after the company issued the recall. The medication manages intraocular pressure in patients with open-angle glaucoma or ocular hypertension.

According to the release, the recall applies to the following six lots: TJ9848, TJ9849, TK0258, TK5341, TK0261, and TK0262. These lots were distributed between April 5, 2022, and February 22, 2023.

The Florida-based company explained that this is a cautious voluntary recall due to cracks found in some of the caps of the solution in question. The organization is concerned about the potential impacts on sterility, with many cracked caps reported. If sterility is compromised, it could cause adverse effects, as seen during the recall of Global Pharma Healthcare’s artificial tears.

Apotex has already issued recall notices and distributed them via email and standard mail to wholesalers, distributors, and other direct accounts. The manufacturer advises that consumers contact Inmar Rx Solutions to return affected lots. Additionally, patients are urged to report any adverse reactions to the FDA MedWatch Adverse Event Reporting program.

Just days after Apotex issued its voluntary recall, on March 3, 2023, Pharmedica USA LLC recalled its soothing drops. The following two lots of Purely Soothing 15% MSM Drops have been affected: 2203PS01 and 1808051.

While attributing the recall to sterility issues, the organization does not identify any specific contaminants. Although the information on the release is vague, the company assures consumers that no one has reported adverse outcomes so far.

Pharmedica, like Apotex, advises patients and distributors to discontinue use, return the product to the original manufacturer, and report any adverse reactions to MedWatch.

After reports of Pseudomonas aeruginosa, VIM-GES-CRPA, a drug-resistant bacteria, in Global Pharma Healthcare’s over-the-counter artificial tears cost five patients their vision and contributed to one patient’s death, providers and patients are growing exceedingly cautious about the sterility of some eye drops.

Unlike Global Pharma Healthcare, the FDA has not highlighted violations of good manufacturing practices by Apotex or Pharmedica. As a result, the two domestic manufacturers will not face the same restrictions as Global Pharma, based in India.