The manufacturer of Purely Soothing eye drops is reminder two batches of the product because they were not sterilized.
As of last week, Phoenix-based Pharmedica USA LLC said it had received no reports of adverse events or illnesses related to the recalled product, which is 15% methylsulfonylmethane (MSM).
The product was distributed worldwide. Users of affected products are at risk of infection and potentially blindness.
The eye drops are used as anti-inflammatories designed to relieve symptoms of eye irritation and/or swelling, and are packaged in white cylindrical bottles. The eye drops (LOT #: 2203PS01, 1 oz, UPC 7 31034 91379 9; and LOT #: 1808051, ½ oz, UPC 7 31034 91382 9) have white dropper caps and lids.
The announcement follows a recall last month of eye drops made in India that were linked to a outbreak of drug-resistant infections. One person died and at least five others suffered permanent vision loss.
Last week, the Food and Drug Administration issued a separate recall announcement from Apotex for six lots of prescription eye drops used to treat a form of glaucoma. The company said it launched the recall after finding cracks in some bottle caps.
There is no indication that the latest recalls are related to these products.
Pharmedica advises customers to immediately stop using the product and return it to the place of purchase. Wholesalers and retailers should stop distribution and immediately return to Pharmedica USA LLC or confirm that the product has been disposed of, with appropriate verification.
Consumers with questions regarding this recall may contact Phmedica USA by phone at +1-623-698-1752 or by email at osm@pharmedicausa.com.