Harvard Drug Group, Cardinal Health voluntarily recall eye drop products
The Harvard Drug Group and Cardinal Health have initiated voluntary recalls on certain over-the-counter ophthalmic products after the FDA warned about unsanitary conditions in the manufacturing facility.
According to a press release from Harvard Drug Group, the company is recalling all lots of Rugby Lubricating Eye Drops (polyvinyl alcohol, 1.4%) and Lubricating Tears Eye Drops (dextran/hypromellose, 0.1%/0.3%). The products were distributed nationwide starting June 1, 2021.
Cardinal Health said in a separate press release that it is recalling all lots of Leader brand eye drops that were distributed nationwide to wholesalers and distributors starting Dec. 12, 2021.
The products include:
- Eye Irritation Relief (polyvinyl alcohol, 0.5%, povidone, 0.6%, and tetrahydrozoline HCl, 0.05%);
- Dry Eye Relief (carboxymethylcellulose sodium, 1%);
- Lubricant Eye Drops (carboxymethylcellulose sodium, 0.5%);
- Dry Eye Relief (polyethylene glycol 400, 0.4% and propylene glycol, 0.3%); and
- Lubricant Eye Drops (propylene glycol, 0.6%).
All of the recalled products from both Harvard and Cardinal were supplied by Velocity Pharma.
To date, the Harvard Drug Group and Cardinal Health have received reports of three adverse events related to the recalled products, including vision blurriness, vision loss and burning eyes, the releases stated. The reports have been shared with Velocity Pharma.
Both companies are sending recall notifications via mail to all affected direct accounts and are arranging for return of the products. In addition, they advised wholesalers, distributors and retailers to cease distribution of these products.
The companies also advised consumers to discontinue use and urged anyone who has signs or symptoms of eye infection after using these products to speak with their health care provider or seek medical care immediately.
Reference:
- The Harvard Drug Group, LLC issues voluntary nationwide recall of certain Rugby Laboratories brand eye drops supplied by Velocity Pharma, LLC due to potential risk of eye infections. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/harvard-drug-group-llc-issues-voluntary-nationwide-recall-certain-rugbyr-laboratories-brand-eye. Published Oct. 31, 2023. Accessed Nov. 3, 2023.
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